CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST— 510(k) K903126

Name: FDA 510(k) clearance K903126
Creator: U.S. Food and Drug Administration
Published: 1990-12-26

Substantially Equivalent

Crystal Diagnostics, Inc.

FDA 510(k) clearance K903126 for CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST, Substantially Equivalent on 1990-12-26. Applicant: Crystal Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Crystal Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1990-07-16
Decision date: 1990-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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