QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA— 510(k) K890267

Name: FDA 510(k) clearance K890267
Creator: U.S. Food and Drug Administration
Published: 1989-04-26

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K890267 for QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA, Substantially Equivalent on 1989-04-26. Applicant: Photec Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1989-01-04
Decision date: 1989-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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