GLYC-AFFIN(TM)-GA— 510(k) K905513

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K905513 for GLYC-AFFIN(TM)-GA, Substantially Equivalent on 1991-01-15. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1990-12-10
Decision date: 1991-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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