The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Gen. Diagnostics Low Fibrinogen Control.
| Device ID | K833352 |
| 510k Number | K833352 |
| Device Name: | GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL |
| Classification | Plasma, Fibrinogen Control |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIL |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-28 |
| Decision Date | 1983-11-03 |