IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT— 510(k) K964010

Name: FDA 510(k) clearance K964010
Creator: U.S. Food and Drug Administration
Published: 1997-02-10

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K964010 for IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT, Substantially Equivalent on 1997-02-10. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1996-10-07
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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