The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom D-di Kit.
| Device ID | K862156 |
| 510k Number | K862156 |
| Device Name: | ASSERACHROM D-DI KIT |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le |
| Correspondent | Loc B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-05 |
| Decision Date | 1986-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009477 | K862156 | 000 |