FDA 510(k) Applications for Medical Device Product Code "JFH"
(Acid Phosphatase (Prostatic), Tartrate Inhibited)

FDA 510(k) Number Applicant Device Name Decision Date
K000257 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 02/23/2000
K981573 UNITED BIOTECH, INC. UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE 09/15/1998
K964756 WANO-TECH CORP. PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT 04/23/1997


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