The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Tpa Test Kit.
| Device ID | K971519 |
| 510k Number | K971519 |
| Device Name: | ASSERACHROM TPA TEST KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1997-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009484 | K971519 | 000 |