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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K921472
Device Name M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
Applicant
Microtest
1379 Brentford Cove
Snelleville,  GA  30278
Applicant Contact JAMES P BRINKER
Correspondent
Microtest
1379 Brentford Cove
Snelleville,  GA  30278
Correspondent Contact JAMES P BRINKER
Regulation Number866.2390
Classification Product Code
JSM  
Date Received03/19/1992
Decision Date 05/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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