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FDA 510(k)

TANDEM PAP KIT - (PARTS I & II)

K-Number: K811959 · 1981-09-01

ApplicantHybritech, Inc.
Decision Date1981-09-01
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM PAP KIT - (PARTS I & II) is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K811959. 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 TANDEM PAP KIT - (PARTS I & II)?

TANDEM PAP KIT - (PARTS I & II) is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Hybritech, Inc.. The 510(k) number is K811959.

When did TANDEM PAP KIT - (PARTS I & II) receive FDA 510(k) clearance?

TANDEM PAP KIT - (PARTS I & II) received FDA 510(k) clearance on 1981-09-01, under 510(k) number K811959.

Who is the listed applicant for TANDEM PAP KIT - (PARTS I & II)?

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

What is the FDA product code for TANDEM PAP KIT - (PARTS I & II)?

The FDA product code for TANDEM PAP KIT - (PARTS I & II) is JFH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

View all 63 devices →

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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