K771198 is an FDA 510(k) clearance for the LUMI-AGGREGOMETER. This device is classified as a Aggregometer, Platelet, Photo-optical Scanning (Class II - Special Controls, product code JBY).
Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on August 2, 1977, 32 days after receiving the submission on July 1, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6675.
| 510(k) Number | K771198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1977 |
| Decision Date | August 02, 1977 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBY — Aggregometer, Platelet, Photo-optical Scanning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6675 |