HEMOCARD(TM) CONTROL— 510(k) K924173

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K924173 for HEMOCARD(TM) CONTROL, Substantially Equivalent on 1992-12-01. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1992-08-19
Decision date: 1992-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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