DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY— 510(k) K914818

Name: FDA 510(k) clearance K914818
Creator: U.S. Food and Drug Administration
Published: 1992-01-15

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K914818 for DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY, Substantially Equivalent on 1992-01-15. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1991-10-25
Decision date: 1992-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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