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FDA 510(k)

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT

K-Number: K821305 · 1982-05-24

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1982-05-24
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-05-24 under 510(k) number K821305. 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 PROLACTIN (125-I) RADIOIMMUNOASSAY KIT?

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821305.

When did PROLACTIN (125-I) RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821305.

Who is the listed applicant for PROLACTIN (125-I) RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLACTIN (125-I) RADIOIMMUNOASSAY KIT?

The FDA product code for PROLACTIN (125-I) RADIOIMMUNOASSAY KIT is CFT.

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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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