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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-reagents, mycobacterium spp.
510(k) Number K900202
Device Name SNAP MYCOBACTERIA AVIUM COMPLEX
Applicant
SYNGENE, INC.
10030 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Applicant Contact PHILIP M FANTASIA
Correspondent
SYNGENE, INC.
10030 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Correspondent Contact PHILIP M FANTASIA
Regulation Number866.3370
Classification Product Code
LQF  
Date Received01/16/1990
Decision Date 04/03/1990
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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