BACTON(TM), AUTO-APO B REAGENT— 510(k) K921862

Name: FDA 510(k) clearance K921862
Creator: U.S. Food and Drug Administration
Published: 1992-06-22

Substantially Equivalent

Bacton Assay Systems, Inc.

FDA 510(k) clearance K921862 for BACTON(TM), AUTO-APO B REAGENT, Substantially Equivalent on 1992-06-22. Applicant: Bacton Assay Systems, Inc.. Device class: 1.

Clearance details

Applicant: Bacton Assay Systems, Inc.
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1992-04-14
Decision date: 1992-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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