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FDA 510(k)

P.A.P. TEST KIT, RIA-ZYME

K-Number: K790040 · 1979-04-17

ApplicantMallinckrodt Critical Care
Decision Date1979-04-17
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

P.A.P. TEST KIT, RIA-ZYME is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1979-04-17 under 510(k) number K790040. 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 P.A.P. TEST KIT, RIA-ZYME?

P.A.P. TEST KIT, RIA-ZYME is a medical device that received FDA 510(k) clearance on 1979-04-17. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K790040.

When did P.A.P. TEST KIT, RIA-ZYME receive FDA 510(k) clearance?

P.A.P. TEST KIT, RIA-ZYME received FDA 510(k) clearance on 1979-04-17, under 510(k) number K790040.

Who is the listed applicant for P.A.P. TEST KIT, RIA-ZYME?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P.A.P. TEST KIT, RIA-ZYME?

The FDA product code for P.A.P. TEST KIT, RIA-ZYME is JFH.

Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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