The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cryo Check Factor Xii Deficient Plasma Model Fdp12-10 (1.0ml) And Fdp12-15 (1.5ml).
| Device ID | K981174 |
| 510k Number | K981174 |
| Device Name: | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia, CA B3b 1p7 |
| Contact | Sandy Morrison |
| Correspondent | Sandy Morrison 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 | 1998-04-01 |
| Decision Date | 1999-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000374 | K981174 | 000 |
| 00843876000367 | K981174 | 000 |