FIBRO-TEC TEST KIT— 510(k) K791358

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K791358 for FIBRO-TEC TEST KIT, Substantially Equivalent on 1979-09-04. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1979-07-24
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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