The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Hbpm/lmwh Control Kit.
| Device ID | K943519 |
| 510k Number | K943519 |
| Device Name: | HBPM/LMWH CONTROL KIT |
| Classification | Assay, Heparin |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le |
| Correspondent | Andrew Loc B Le AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1995-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006827 | K943519 | 000 |