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FDA 510(k)

CBC PAP TEST KIT

K-Number: K802153 · 1980-11-12

ApplicantCalbiochem-Behring Corp.
Decision Date1980-11-12
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CBC PAP TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802153. 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 CBC PAP TEST KIT?

CBC PAP TEST KIT is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K802153.

When did CBC PAP TEST KIT receive FDA 510(k) clearance?

CBC PAP TEST KIT received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802153.

Who is the listed applicant for CBC PAP TEST KIT?

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

What is the FDA product code for CBC PAP TEST KIT?

The FDA product code for CBC PAP TEST KIT is JFH.

Other records listing Calbiochem-Behring Corp. 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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK820812CREATINE KINASE-MB KITK813493ENZYGNOST TM RUBELLA IGMK820088AFT SYSTEM PROFICIENCY TESTING PROGRAM

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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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