Name: Predicase
Price: 199 USD

K-number	K974572
Device name	GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
Applicant	Chugai Pharmaceuticals Co., Ltd.
Product code	MDK
Device class	Class I
Decision date	Sep 24, 1998
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820

Everything you need for a 510(k) submission. Nothing you don't.