← Product Code [JQY](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQY) · K952178

# PH-DETECT TEST (K952178)

_Diagnostic Reagents, Inc. · JQY · Oct 20, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQY/K952178

## Device Facts

- **Applicant:** Diagnostic Reagents, Inc.
- **Product Code:** [JQY](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQY.md)
- **Decision Date:** Oct 20, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2050
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQY/K952178](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQY/K952178)

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