The following data is part of a premarket notification filed by Biotraces, Inc. with the FDA for Sequential Sample Multi-photon Detector.
| Device ID | K962762 |
| 510k Number | K962762 |
| Device Name: | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | BIOTRACES, INC. 10517-A WEST DR. Fairfax, VA 22030 |
| Contact | James E Wadiak |
| Correspondent | James E Wadiak BIOTRACES, INC. 10517-A WEST DR. Fairfax, VA 22030 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-08-16 |
| Summary: | summary |