The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Fs Test Kit.
| Device ID | K854015 |
| 510k Number | K854015 |
| Device Name: | FS TEST KIT |
| Classification | Fibrin Monomer Paracoagulation |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | B Le |
| Correspondent | B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | JBN |
| CFR Regulation Number | 864.7300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1986-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450008876 | K854015 | 000 |
| 03607450008579 | K854015 | 000 |