The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Fibrinogen High Abnormal Control - Level 3.
| Device ID | K946265 |
| 510k Number | K946265 |
| Device Name: | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 |
| Classification | Plasma, Fibrinogen Control |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | GIL |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-08-24 |