MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM— 510(k) K921556

Name: FDA 510(k) clearance K921556
Creator: U.S. Food and Drug Administration
Published: 1992-06-29

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K921556 for MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM, Substantially Equivalent on 1992-06-29. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Product code LJZ
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1992-04-01
Decision date: 1992-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

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