The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Fdp Plasma Test Kit.
| Device ID | K920943 |
| 510k Number | K920943 |
| Device Name: | FDP PLASMA TEST 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 | 1992-02-27 |
| Decision Date | 1992-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450005513 | K920943 | 000 |
| 13607450005414 | K920943 | 000 |
| 03607450005400 | K920943 | 000 |