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FDA 510(k)

TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY

K-Number: K961477 · 1996-08-05

ApplicantTrace America, Inc.
Decision Date1996-08-05
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY 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 1996-08-05 under 510(k) number K961477. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY?

TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY is a medical device that received FDA 510(k) clearance on 1996-08-05. The listed applicant is Trace America, Inc.. The 510(k) number is K961477.

When did TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY receive FDA 510(k) clearance?

TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY received FDA 510(k) clearance on 1996-08-05, under 510(k) number K961477.

Who is the listed applicant for TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY?

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 TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY?

The FDA product code for TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY is CDT.

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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: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, 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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