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FDA 510(k)

PAP-CHECK RIA KIT

K-Number: K792043 · 1979-10-30

ApplicantSerono Laboratories, Inc.
Decision Date1979-10-30
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PAP-CHECK RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792043. 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 PAP-CHECK RIA KIT?

PAP-CHECK RIA KIT is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K792043.

When did PAP-CHECK RIA KIT receive FDA 510(k) clearance?

PAP-CHECK RIA KIT received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792043.

Who is the listed applicant for PAP-CHECK RIA KIT?

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

What is the FDA product code for PAP-CHECK RIA KIT?

The FDA product code for PAP-CHECK RIA KIT is JFH.

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Other records listing Serono Laboratories, Inc. as applicant

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.

K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITK810695ESTRIOL RADIOIMMUNOASSAY TEST KITK810625HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-K790679ESTRADIOL RIA KITK790440PROGESTERONEK782143RIA KIT, GLUCOSE

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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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