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FDA 510(k)

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION

K-Number: K904458 · 1990-10-12

ApplicantLondon Diagnostics, Inc.
Decision Date1990-10-12
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is London Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-10-12 under 510(k) number K904458. 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 LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION?

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-10-12. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K904458.

When did LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION receive FDA 510(k) clearance?

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION received FDA 510(k) clearance on 1990-10-12, under 510(k) number K904458.

Who is the listed applicant for LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION?

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

What is the FDA product code for LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION?

The FDA product code for LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION is CFT.

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Other records listing London Diagnostics, 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.

K914835LUMATAG FREE T4 CHEMILUMINESCENCE ASSAYK911985LUMATAG T4 CHEMILUMINESCENCE ASSAYK912858LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAYK905814LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAYK903130LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAYK902443LUMATAG(TM) LH DIAGNOSTIC 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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