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FDA 510(k)

ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM

K-Number: K853717 · 1985-10-02

ApplicantNichols Institute Diagnostics
Decision Date1985-10-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1985-10-02 under 510(k) number K853717. 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 TM HS-TSH IMMUNOASSAY SYSTEM?

ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-02. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K853717.

When did ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1985-10-02, under 510(k) number K853717.

Who is the listed applicant for ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM?

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

What is the FDA product code for ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM?

The FDA product code for ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM is JLW.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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