The following data is part of a premarket notification filed by Altana, Inc. with the FDA for Ria/mat Fpa Test Kit.
| Device ID | K884496 |
| 510k Number | K884496 |
| Device Name: | RIA/MAT FPA TEST KIT |
| Classification | Fibrinopeptide A, Antigen, Antiserum, Control |
| Applicant | ALTANA, INC. 60 BAYLIS RD. Melville, NY 11747 |
| Contact | Clair, Phd |
| Correspondent | Clair, Phd ALTANA, INC. 60 BAYLIS RD. Melville, NY 11747 |
| Product Code | DAN |
| CFR Regulation Number | 866.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1988-11-16 |