← Product Code [JJJ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ) · K830751

# KEMTEK 102 (K830751)

_Kemble Instruments, Inc. · JJJ · Apr 6, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K830751

## Device Facts

- **Applicant:** Kemble Instruments, Inc.
- **Product Code:** [JJJ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ.md)
- **Decision Date:** Apr 6, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2320
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K830751](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJJ/K830751)

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