The following data is part of a premarket notification filed by More Diagnostics with the FDA for Fibrin(ogen) Fdp Control Level 1 & Level 2.
| Device ID | K932657 |
| 510k Number | K932657 |
| Device Name: | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, 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 | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-11-02 |