HEMOCARD-AS— 510(k) K910430

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K910430 for HEMOCARD-AS, Substantially Equivalent on 1991-04-15. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1991-02-01
Decision date: 1991-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.