Duns Number:072915986
Device Description: A multi-parameter hematology control for small laboratories and point-of-care applications A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of low, normal & high levels.
Catalog Number
215412
Brand Name
Para 4
Version/Model Number
215412
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
K842017
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
f70293cc-6c02-42ef-9337-60d6a7a68c62
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |