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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
Original Applicant
CHUGAI PHARMACEUTICALS CO., LTD.
10210 genetic center dr.
san diego,  CA  92121
Original Contact gerald h schell
Regulation Number866.3740
Classification Product Code
MDK  
Date Received12/05/1997
Decision Date 09/24/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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