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)

LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L

K-Number: K121084 · 2012-05-09

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2012-05-09
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-05-09 under 510(k) number K121084. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L?

LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L is a medical device that received FDA 510(k) clearance on 2012-05-09. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K121084.

When did LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L receive FDA 510(k) clearance?

LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L received FDA 510(k) clearance on 2012-05-09, under 510(k) number K121084.

Who is the listed applicant for LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L?

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

What is the FDA product code for LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L?

The FDA product code for LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L is JJX.

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 Siemens Healthcare Diagnostics, 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.

K253528Atellica IM CA 19-9 IIK261364Atellica CH Acetaminophen 2 (ACTM)K251998Atellica CH Diazo Total Bilirubin (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM Total PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

View all 114 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑