Name: Predicase
Price: 199 USD

K-number	K060452
Device name	ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
Applicant	Neo-Genesis
Product code	JLX
Device class	Class I
Decision date	Mar 13, 2007
Decision	Substantially Equivalent
Regulation	862.1395

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View the full FDA submission: accessdata.fda.gov

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ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH

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