The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Thrombin-prest Reagent Kit.
| Device ID | K884384 |
| 510k Number | K884384 |
| Device Name: | THROMBIN-PREST REAGENT KIT |
| Classification | Test, Thrombin Time |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le,phd |
| Correspondent | Loc B Le,phd AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1988-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450006695 | K884384 | 000 |
| 13607450006114 | K884384 | 000 |