ORTHO APO B ELISA TEST SYSTEM— 510(k) K895277

Name: FDA 510(k) clearance K895277
Creator: U.S. Food and Drug Administration
Published: 1989-09-27

Substantially Equivalent

Medical Marketing Consultants, Inc.

FDA 510(k) clearance K895277 for ORTHO APO B ELISA TEST SYSTEM, Substantially Equivalent on 1989-09-27. Applicant: Medical Marketing Consultants, Inc.. Device class: 1.

Clearance details

Applicant: Medical Marketing Consultants, Inc.
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1989-08-23
Decision date: 1989-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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