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FDA 510(k)

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K-Number: K980026 · 1998-03-10

ApplicantTrace America, Inc.
Decision Date1998-03-10
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (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 1998-03-10 under 510(k) number K980026. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)?

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Trace America, Inc.. The 510(k) number is K980026.

When did GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) receive FDA 510(k) clearance?

GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) received FDA 510(k) clearance on 1998-03-10, under 510(k) number K980026.

Who is the listed applicant for GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (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 GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)?

The FDA product code for GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is CFR.

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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 TR66901K980028ALT (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)K972297AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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