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FDA 510(k)

THYROTROPIN(TSH) ELISA

K-Number: K971780 · 1997-06-24

ApplicantMonobind
Decision Date1997-06-24
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROTROPIN(TSH) ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971780. 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 THYROTROPIN(TSH) ELISA?

THYROTROPIN(TSH) ELISA is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Monobind. The 510(k) number is K971780.

When did THYROTROPIN(TSH) ELISA receive FDA 510(k) clearance?

THYROTROPIN(TSH) ELISA received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971780.

Who is the listed applicant for THYROTROPIN(TSH) ELISA?

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

What is the FDA product code for THYROTROPIN(TSH) ELISA?

The FDA product code for THYROTROPIN(TSH) ELISA is JLW.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

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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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