DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA— 510(k) K920895

Name: FDA 510(k) clearance K920895
Creator: U.S. Food and Drug Administration
Published: 1992-06-04

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K920895 for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA, Substantially Equivalent on 1992-06-04. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code MIF
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1992-02-26
Decision date: 1992-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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