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)

QUANTIMETRIX AMMONIA CONTROLS

K-Number: K913346 · 1991-09-25

ApplicantQuantimetrix Corp.
Decision Date1991-09-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX AMMONIA CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913346. 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 QUANTIMETRIX AMMONIA CONTROLS?

QUANTIMETRIX AMMONIA CONTROLS is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Quantimetrix Corp.. The 510(k) number is K913346.

When did QUANTIMETRIX AMMONIA CONTROLS receive FDA 510(k) clearance?

QUANTIMETRIX AMMONIA CONTROLS received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913346.

Who is the listed applicant for QUANTIMETRIX AMMONIA CONTROLS?

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

What is the FDA product code for QUANTIMETRIX AMMONIA CONTROLS?

The FDA product code for QUANTIMETRIX AMMONIA CONTROLS 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 Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

View all 37 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.

↑