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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-probe, reagents, streptococcal
510(k) Number K974572
Device Name GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
Applicant
CHUGAI PHARMACEUTICALS CO., LTD.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121
Applicant Contact GERALD H SCHELL
Correspondent
CHUGAI PHARMACEUTICALS CO., LTD.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121
Correspondent Contact GERALD H SCHELL
Regulation Number866.3740
Classification Product Code
MDK  
Date Received12/05/1997
Decision Date 09/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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