Name: Predicase
Price: 199 USD

K-number	K121046
Device name	STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
Applicant	Kronus Market Development Associates, Inc.
Product code	PCG
Device class	Class II
Decision date	Dec 20, 2012
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

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