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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
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
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