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FDA 510(k)

CENTRIA PROLACTIN TEST SET

K-Number: K813572 · 1982-03-26

ApplicantVentrex Laboratories, Inc.
Decision Date1982-03-26
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIA PROLACTIN TEST SET 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 1982-03-26 under 510(k) number K813572. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIA PROLACTIN TEST SET?

CENTRIA PROLACTIN TEST SET is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K813572.

When did CENTRIA PROLACTIN TEST SET receive FDA 510(k) clearance?

CENTRIA PROLACTIN TEST SET received FDA 510(k) clearance on 1982-03-26, under 510(k) number K813572.

Who is the listed applicant for CENTRIA PROLACTIN TEST SET?

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 CENTRIA PROLACTIN TEST SET?

The FDA product code for CENTRIA PROLACTIN TEST SET is CFT.

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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

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Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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