REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST— 510(k) K942093

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K942093 for REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST, Substantially Equivalent on 1994-11-28. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 1.

Clearance details

Applicant
Medical Diagnostic Technologies, Inc.
Product code
Code GTZ
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Augusta, GA, US
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