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FDA 510(k)

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

K-Number: K964756 · 1997-04-23

ApplicantWano-Tech Corp.
Decision Date1997-04-23
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wano-Tech Corp.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K964756. The device is classified under product code JFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT?

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Wano-Tech Corp.. The 510(k) number is K964756.

When did PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT receive FDA 510(k) clearance?

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT received FDA 510(k) clearance on 1997-04-23, under 510(k) number K964756.

Who is the listed applicant for PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT?

The FDA 510(k) record lists Wano-Tech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT?

The FDA product code for PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT is JFH.

Related Clinical Trials

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Related Devices (Code: JFH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6Diagnostic Products Corp.K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEUnited Biotech, Inc.K931701IMMULITE PAPDiagnostic Products Corp.K925377IMX PAPAbbott LaboratoriesK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOHybritech, Inc.K902937MILENIA PAP IRMA CATALOG #: MKPA1, XDiagnostic Products Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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