THERMO SHANDON LIMITED

THERMO SHANDON LIMITED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Slide Stainer, Automated (KPA) (6) Cytocentrifuge (IFB) (2) Dispensers, Paraffin (IDW) (1) Processor, Tissue, Automated (IEO) (1)

Premarket Exempt

Yes

Clear

Thermo Fisher - 00505166300228 Catalog Number :

Device Description : 220-240V 50/60 Hz

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Epredia - 00505166300938 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001076 Catalog Number :

Device Description : 100-240V 50/60HZ WITH STARTER KIT

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IFB

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001137 Catalog Number :

Device Description : 100-240V 50/60HZ WITHOUT STARTER KIT

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IFB

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001595 Catalog Number :

Device Description : SLIDE STAINER 115V 60HZ

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001601 Catalog Number :

Device Description : SLIDE STAINER 230V 50HZ

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001663 Catalog Number :

Device Description : 2D 240v

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001670 Catalog Number :

Device Description : 2D 120V

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001687 Catalog Number :

Device Description : 240v

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001694 Catalog Number :

Device Description : 120v 2D BARCODE PC & PERIPHERALS DATA CABLE & FULL ACCESSORY KIT

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

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