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FDA 510(k)

AXSYM ULTRASENSITIVE HTSH

K-Number: K934410 · 1994-06-21

ApplicantAbbott Laboratories
Decision Date1994-06-21
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM ULTRASENSITIVE HTSH is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K934410. 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 AXSYM ULTRASENSITIVE HTSH?

AXSYM ULTRASENSITIVE HTSH is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Abbott Laboratories. The 510(k) number is K934410.

When did AXSYM ULTRASENSITIVE HTSH receive FDA 510(k) clearance?

AXSYM ULTRASENSITIVE HTSH received FDA 510(k) clearance on 1994-06-21, under 510(k) number K934410.

Who is the listed applicant for AXSYM ULTRASENSITIVE HTSH?

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

What is the FDA product code for AXSYM ULTRASENSITIVE HTSH?

The FDA product code for AXSYM ULTRASENSITIVE HTSH is JLW.

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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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