QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT— 510(k) K897169

Name: FDA 510(k) clearance K897169
Creator: U.S. Food and Drug Administration
Published: 1990-02-23

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K897169 for QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT, Substantially Equivalent on 1990-02-23. Applicant: Photec Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1989-12-28
Decision date: 1990-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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