QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY— 510(k) K942276

Name: FDA 510(k) clearance K942276
Creator: U.S. Food and Drug Administration
Published: 1995-01-20

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K942276 for QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY, Substantially Equivalent on 1995-01-20. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GIQ
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1994-05-10
Decision date: 1995-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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