QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT— 510(k) K761058

Name: FDA 510(k) clearance K761058
Creator: U.S. Food and Drug Administration
Published: 1977-02-07

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K761058 for QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT, Substantially Equivalent on 1977-02-07. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1976-11-18
Decision date: 1977-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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