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FDA 510(k)

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY

K-Number: K903130 · 1990-09-25

ApplicantLondon Diagnostics, Inc.
Decision Date1990-09-25
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY 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 1990-09-25 under 510(k) number K903130. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY?

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY is a medical device that received FDA 510(k) clearance on 1990-09-25. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K903130.

When did LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY receive FDA 510(k) clearance?

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY received FDA 510(k) clearance on 1990-09-25, under 510(k) number K903130.

Who is the listed applicant for LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY?

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 LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY?

The FDA product code for LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY is CEW.

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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 ASSAYK904458LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATIONK902443LUMATAG(TM) LH DIAGNOSTIC KIT

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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