K-number	K954418
Device name	INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
Applicant	Nichols Institute Diagnostics
Product code	CEW
Device class	Class II
Decision date	Nov 3, 1995
Decision	Substantially Equivalent
Regulation	862.1545

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INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)

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