Name: Predicase
Price: 199 USD

K-number	K001411
Device name	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
Applicant	Scantibodies Laboratory, Inc.
Product code	CEW
Device class	Class II
Decision date	Aug 21, 2000
Decision	Substantially Equivalent
Regulation	862.1545

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Source

View the full FDA submission: accessdata.fda.gov

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WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056

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