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FDA 510(k)

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

K-Number: K921745 · 1992-07-30

ApplicantHybritech, Inc.
Decision Date1992-07-30
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K921745. 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 HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO?

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Hybritech, Inc.. The 510(k) number is K921745.

When did HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO receive FDA 510(k) clearance?

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO received FDA 510(k) clearance on 1992-07-30, under 510(k) number K921745.

Who is the listed applicant for HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO?

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 HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO?

The FDA product code for HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO 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 SETK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROLK920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

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 LaboratoriesK902937MILENIA PAP IRMA CATALOG #: MKPA1, XDiagnostic Products Corp.

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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