The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Aptt Reagent.
| Device ID | K884856 |
| 510k Number | K884856 |
| Device Name: | APTT REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Contact | Tony Bebbington |
| Correspondent | Tony Bebbington PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-01-30 |