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FDA 510(k)

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC

K-Number: K843230 · 1984-09-04

ApplicantVentrex Laboratories, Inc.
Decision Date1984-09-04
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-04 under 510(k) number K843230. 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 VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC?

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K843230.

When did VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC receive FDA 510(k) clearance?

VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC received FDA 510(k) clearance on 1984-09-04, under 510(k) number K843230.

Who is the listed applicant for VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC?

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

What is the FDA product code for VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC?

The FDA product code for VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC is JFH.

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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 Ventrex 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

View all 82 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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