QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT— 510(k) K894057

Name: FDA 510(k) clearance K894057
Creator: U.S. Food and Drug Administration
Published: 1989-08-31

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K894057 for QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT, Substantially Equivalent on 1989-08-31. Applicant: Photec Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1989-06-07
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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