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FDA 510(k)

CARBON DIOXIDE - DST

K-Number: K960035 · 1996-04-08

ApplicantTrace America, Inc.
Decision Date1996-04-08
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE - DST is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 1996-04-08 under 510(k) number K960035. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON DIOXIDE - DST?

CARBON DIOXIDE - DST is a medical device that received FDA 510(k) clearance on 1996-04-08. The listed applicant is Trace America, Inc.. The 510(k) number is K960035.

When did CARBON DIOXIDE - DST receive FDA 510(k) clearance?

CARBON DIOXIDE - DST received FDA 510(k) clearance on 1996-04-08, under 510(k) number K960035.

Who is the listed applicant for CARBON DIOXIDE - DST?

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

What is the FDA product code for CARBON DIOXIDE - DST?

The FDA product code for CARBON DIOXIDE - DST is KHS.

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 Trace America, 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.

K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K973869TRACE REAGENT LINE FOR THE COBAS MIRAK974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

View all 22 devices →

Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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