MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM— 510(k) K883083

Name: FDA 510(k) clearance K883083
Creator: U.S. Food and Drug Administration
Published: 1988-10-25

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K883083 for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM, Substantially Equivalent on 1988-10-25. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code GSA
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1988-07-21
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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