The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cryo Check Inr Validation Set.
| Device ID | K971219 |
| 510k Number | K971219 |
| Device Name: | CRYO CHECK INR VALIDATION SET |
| Classification | Plasma, Coagulation Control |
| Applicant | PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia, CA B3b 1p7 |
| Contact | Stephen L Duff |
| Correspondent | Stephen L Duff PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia, CA B3b 1p7 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-08-29 |