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FDA 510(k)

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM

K-Number: K903391 · 1990-10-12

ApplicantNichols Institute
Decision Date1990-10-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1990-10-12 under 510(k) number K903391. 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 ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM?

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM is a medical device that received FDA 510(k) clearance on 1990-10-12. The listed applicant is Nichols Institute. The 510(k) number is K903391.

When did ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM receive FDA 510(k) clearance?

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM received FDA 510(k) clearance on 1990-10-12, under 510(k) number K903391.

Who is the listed applicant for ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM?

The FDA 510(k) record lists Nichols Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM?

The FDA product code for ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM is JLW.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

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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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