K781807 is an FDA 510(k) clearance for the REAGENT, FIREFLY #395. This device is classified as a System, Automated Platelet Aggregation (Class II - Special Controls, product code JOZ).
Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on November 22, 1978, 28 days after receiving the submission on October 25, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K781807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1978 |
| Decision Date | November 22, 1978 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JOZ — System, Automated Platelet Aggregation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5700 |