FDA 510(k) Application Details - K974572

Device Classification Name Dna-Probe, Reagents, Streptococcal

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510(K) Number K974572
Device Name Dna-Probe, Reagents, Streptococcal
Applicant CHUGAI PHARMACEUTICALS CO., LTD.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121 US
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Contact GERALD H SCHELL
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Regulation Number 866.3740

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Classification Product Code MDK
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Date Received 12/05/1997
Decision Date 09/24/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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