Duns Number:388240673
Device Description: The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro d The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Catalog Number
10805311
Brand Name
Hematek® 3000 System
Version/Model Number
10805311
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K771559
Product Code
KPA
Product Code Name
SLIDE STAINER, AUTOMATED
Public Device Record Key
a4d16695-9a08-4cbb-9fbd-1ecaa376c565
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |