K833352 is an FDA 510(k) clearance for the GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL. This device is classified as a Plasma, Fibrinogen Control (Class II - Special Controls, product code GIL).
Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 36 days after receiving the submission on September 28, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K833352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1983 |
| Decision Date | November 03, 1983 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIL — Plasma, Fibrinogen Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |