Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMX ULTRASENTITIVE HTSH

K-Number: K902753 · 1990-07-10

ApplicantAbbott Mfg., Inc.
Decision Date1990-07-10
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX ULTRASENTITIVE HTSH is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1990-07-10 under 510(k) number K902753. 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 IMX ULTRASENTITIVE HTSH?

IMX ULTRASENTITIVE HTSH is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K902753.

When did IMX ULTRASENTITIVE HTSH receive FDA 510(k) clearance?

IMX ULTRASENTITIVE HTSH received FDA 510(k) clearance on 1990-07-10, under 510(k) number K902753.

Who is the listed applicant for IMX ULTRASENTITIVE HTSH?

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

What is the FDA product code for IMX ULTRASENTITIVE HTSH?

The FDA product code for IMX ULTRASENTITIVE HTSH is JLW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abbott Mfg., 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.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEK953656ABBOTT IMX PROLACTIN(MODIFICATION)

View all 14 devices →

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.

↑