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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunoabsorbent assay, (chlamydiae group)
510(k) Number K951010
Device Name CHLAMYDIA OIA
Applicant
BIOSTAR, INC.
6655 LOOKOUT RD.
BOULDER,  CO  80301
Applicant Contact DAN W CHILDERS
Correspondent
BIOSTAR, INC.
6655 LOOKOUT RD.
BOULDER,  CO  80301
Correspondent Contact DAN W CHILDERS
Regulation Number866.3120
Classification Product Code
LJC  
Date Received03/06/1995
Decision Date 10/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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