Duns Number:315539452
Device Description: The instrument has been designed so that it is safe to use by the operator as well as for The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens.
Catalog Number
14047643514
Brand Name
Leica ASP300 S - 230-240V
Version/Model Number
000000014047643514
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IEO
Product Code Name
PROCESSOR, TISSUE, AUTOMATED
Public Device Record Key
0162a154-f7ed-431a-9112-0f2e569af440
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
December 04, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 97 |