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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 K914894
Device Name VIRAPURE, CHLAMYPURE AND MYCOPURE
Applicant
Microtest
1379 Brentford Cove
Snelleville,  GA  30278
Applicant Contact JAMES BINKER
Correspondent
Microtest
1379 Brentford Cove
Snelleville,  GA  30278
Correspondent Contact JAMES BINKER
Regulation Number866.2390
Classification Product Code
JSM  
Date Received10/31/1991
Decision Date 12/18/1991
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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