CEPHALINEX ACTIVATED PTT REAGENT— 510(k) K852195

Name: FDA 510(k) clearance K852195
Creator: U.S. Food and Drug Administration
Published: 1985-08-12

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K852195 for CEPHALINEX ACTIVATED PTT REAGENT, Substantially Equivalent on 1985-08-12. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1985-05-20
Decision date: 1985-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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