K812628 is an FDA 510(k) clearance for the ACA FIBRINOGEN CALIBRATOR. This device is classified as a Fibrinogen Standard (Class II — Special Controls, product code GFX).
Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981, 70 days after receiving the submission on September 15, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K812628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1981 |
| Decision Date | November 24, 1981 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GFX — Fibrinogen Standard |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7340 |