Name: Predicase
Price: 199 USD

K-number	K964756
Device name	PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
Applicant	Wano-Tech Corp.
Product code	JFH
Device class	Class II
Decision date	Apr 23, 1997
Decision	Substantially Equivalent
Regulation	862.1020

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Source

View the full FDA submission: accessdata.fda.gov

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PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

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