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FDA 510(k)

ELISA TUBE TSH TEST

K-Number: K921958 · 1992-07-02

ApplicantBio Clinic Co.
Decision Date1992-07-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELISA TUBE TSH TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio Clinic Co.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K921958. 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 ELISA TUBE TSH TEST?

ELISA TUBE TSH TEST is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Bio Clinic Co.. The 510(k) number is K921958.

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

ELISA TUBE TSH TEST received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921958.

Who is the listed applicant for ELISA TUBE TSH TEST?

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

What is the FDA product code for ELISA TUBE TSH TEST?

The FDA product code for ELISA TUBE TSH TEST is JLW.

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Other records listing Bio Clinic Co. 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.

K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600K932480PRISMK926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEK922140ORTHODERM CONVERTIBLE IIK921211NOW PREGNANCY TEST KITK921212MIRCO ELISA HPL TEST KIT

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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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