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FDA 510(k)

LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY

K-Number: K881443 · 1988-05-27

ApplicantLondon Diagnostics, Inc.
Decision Date1988-05-27
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. 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 1988-05-27 under 510(k) number K881443. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY?

LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K881443.

When did LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY receive FDA 510(k) clearance?

LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881443.

Who is the listed applicant for LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. 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 LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY?

The FDA product code for LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY is JLW.

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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

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Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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