HEMOCARD, HEMOGLOBIN C ASSAY— 510(k) K923153

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K923153 for HEMOCARD, HEMOGLOBIN C ASSAY, Substantially Equivalent on 1994-01-27. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code MLL
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1992-06-29
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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