ORTHO *APO A-1 ELISA TEST SYSTEM— 510(k) K895160

Name: FDA 510(k) clearance K895160
Creator: U.S. Food and Drug Administration
Published: 1989-10-06

Substantially Equivalent

Medical Marketing Consultants, Inc.

FDA 510(k) clearance K895160 for ORTHO *APO A-1 ELISA TEST SYSTEM, Substantially Equivalent on 1989-10-06. Applicant: Medical Marketing Consultants, Inc.. Device class: 1.

Clearance details

Applicant: Medical Marketing Consultants, Inc.
Product code: Code DEL
Device class: Class 1
Regulation: 21 CFR 866.5590
Advisory panel: Immunology
Date received: 1989-08-23
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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