K962762 is an FDA 510(k) clearance for the SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Biotraces, Inc. (Fairfax, US). The FDA issued a Cleared decision on August 16, 1996, 31 days after receiving the submission on July 16, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K962762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1996 |
| Decision Date | August 16, 1996 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |