D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.— 510(k) K896329

Name: FDA 510(k) clearance K896329
Creator: U.S. Food and Drug Administration
Published: 1989-12-12

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K896329 for D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA., Substantially Equivalent on 1989-12-12. Applicant: Photec Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1989-11-02
Decision date: 1989-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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