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FDA 510(k)

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT

K-Number: K914756 · 1992-01-15

ApplicantMedix Biotech, Inc.
Decision Date1992-01-15
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K914756. 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 ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT?

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K914756.

When did ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT receive FDA 510(k) clearance?

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914756.

Who is the listed applicant for ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT?

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

What is the FDA product code for ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT?

The FDA product code for ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT is JLW.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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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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