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FDA 510(k)

ESKACHEM PAP REAGENT

K-Number: K803234 · 1981-02-26

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-02-26
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESKACHEM PAP REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-02-26 under 510(k) number K803234. 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 ESKACHEM PAP REAGENT?

ESKACHEM PAP REAGENT is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K803234.

When did ESKACHEM PAP REAGENT receive FDA 510(k) clearance?

ESKACHEM PAP REAGENT received FDA 510(k) clearance on 1981-02-26, under 510(k) number K803234.

Who is the listed applicant for ESKACHEM PAP REAGENT?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESKACHEM PAP REAGENT?

The FDA product code for ESKACHEM PAP REAGENT 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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