K781710 is an FDA 510(k) clearance for the BUFFER, COLLAGEN REAGENT AND DILUENT. This device is classified as a Aggregrometer, Platelet (Class II - Special Controls, product code JBX).
Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 19 days after receiving the submission on October 5, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6675.
| 510(k) Number | K781710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1978 |
| Decision Date | October 24, 1978 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBX — Aggregrometer, Platelet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6675 |