# K962762: Sequential Sample Multi-Photon Detector

- Pathway: 510(k) (Traditional)
- Applicant: Biotraces, Inc.
- Decided: Aug 16, 1996 after 31 days
- Product code: JJJ (Counter (Beta, Gamma) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770088 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770088: Gamma 4000 Scintillation Counter, Beckman Instruments, Inc. (1977) Summary page 1.

## Indications for use
The SSMPD is intended as a general use clinical laboratory gamma radiation counter. The SSMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).

Source page: https://510kreport.com/device/K962762
Methodology: https://510kreport.com/methodology