Name: Predicase
Price: 199 USD

K-number	K000566
Device name	MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LTJ
Device class	Class II
Decision date	Mar 9, 2000
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

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