The following data is part of a premarket notification filed by More Diagnostics with the FDA for Fibrinogen Control (human) Level 1, 2, 3.
| Device ID | K946193 |
| 510k Number | K946193 |
| Device Name: | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 |
| Classification | Plasma, Fibrinogen Control |
| Applicant | MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Product Code | GIL |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-08-24 |