Name: Predicase
Price: 199 USD

K-number	K980716
Device name	ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
Applicant	Nichols Institute Diagnostics
Product code	LTJ
Device class	Class II
Decision date	Apr 3, 1998
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

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