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FDA 510(k)

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY

K-Number: K903195 · 1990-08-02

ApplicantLondon Diagnostics, Inc.
Decision Date1990-08-02
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM 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 1990-08-02 under 510(k) number K903195. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY?

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY is a medical device that received FDA 510(k) clearance on 1990-08-02. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K903195.

When did LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY receive FDA 510(k) clearance?

LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY received FDA 510(k) clearance on 1990-08-02, under 510(k) number K903195.

Who is the listed applicant for LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM 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 (R) IGE CHEM. IMM ASSAY?

The FDA product code for LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY is DGC.

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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/MODIFICATIONK903130LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY

View all 12 devices →

Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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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