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FDA 510(k)

TSH-STAT

K-Number: K844583 · 1985-03-05

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1985-03-05
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K844583. 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 TSH-STAT?

TSH-STAT is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K844583.

When did TSH-STAT receive FDA 510(k) clearance?

TSH-STAT received FDA 510(k) clearance on 1985-03-05, under 510(k) number K844583.

Who is the listed applicant for TSH-STAT?

The FDA 510(k) record lists Nuclear Medical Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSH-STAT?

The FDA product code for TSH-STAT is JLW.

Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK840466NML CORTISOL RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEMK823679NML 6000 CT

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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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