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FDA 510(k)

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI

K-Number: K893508 · 1989-08-04

ApplicantBaxter Healthcare Corp
Decision Date1989-08-04
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-08-04 under 510(k) number K893508. 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 PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI?

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI is a medical device that received FDA 510(k) clearance on 1989-08-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K893508.

When did PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI receive FDA 510(k) clearance?

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI received FDA 510(k) clearance on 1989-08-04, under 510(k) number K893508.

Who is the listed applicant for PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI?

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

What is the FDA product code for PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI?

The FDA product code for PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI is JFH.

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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.K964756PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KITWano-Tech Corp.K931701IMMULITE PAPDiagnostic Products Corp.K925377IMX PAPAbbott LaboratoriesK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOHybritech, Inc.

Official Source

View on FDA Database →

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

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