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FDA 510(k)

PROLACTIN RIABEAD II DIAGNOSTIC KIT

K-Number: K863240 · 1986-09-29

ApplicantAbbott Laboratories
Decision Date1986-09-29
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN RIABEAD II DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863240. 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 RIABEAD II DIAGNOSTIC KIT?

PROLACTIN RIABEAD II DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Abbott Laboratories. The 510(k) number is K863240.

When did PROLACTIN RIABEAD II DIAGNOSTIC KIT receive FDA 510(k) clearance?

PROLACTIN RIABEAD II DIAGNOSTIC KIT received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863240.

Who is the listed applicant for PROLACTIN RIABEAD II DIAGNOSTIC KIT?

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

What is the FDA product code for PROLACTIN RIABEAD II DIAGNOSTIC KIT?

The FDA product code for PROLACTIN RIABEAD II DIAGNOSTIC 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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