The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cryo Check Factor Viii Deficient Plasma.
| Device ID | K971225 |
| 510k Number | K971225 |
| Device Name: | CRYO CHECK FACTOR VIII DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| 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 | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000299 | K971225 | 000 |
| 00843876000282 | K971225 | 000 |
| 00843876000275 | K971225 | 000 |