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FDA 510(k)

DELFIA (TM) HUMAN PROLACTIN

K-Number: K861542 · 1986-06-17

ApplicantLkb Instruments, Inc.
Decision Date1986-06-17
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA (TM) HUMAN PROLACTIN is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K861542. 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 DELFIA (TM) HUMAN PROLACTIN?

DELFIA (TM) HUMAN PROLACTIN is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K861542.

When did DELFIA (TM) HUMAN PROLACTIN receive FDA 510(k) clearance?

DELFIA (TM) HUMAN PROLACTIN received FDA 510(k) clearance on 1986-06-17, under 510(k) number K861542.

Who is the listed applicant for DELFIA (TM) HUMAN PROLACTIN?

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

What is the FDA product code for DELFIA (TM) HUMAN PROLACTIN?

The FDA product code for DELFIA (TM) HUMAN PROLACTIN is CFT.

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Other records listing Lkb Instruments, 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) 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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