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FDA 510(k)

URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K-Number: K971485 · 1997-05-27

ApplicantTrace America, Inc.
Decision Date1997-05-27
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID - 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 1997-05-27 under 510(k) number K971485. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)?

URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is a medical device that received FDA 510(k) clearance on 1997-05-27. The listed applicant is Trace America, Inc.. The 510(k) number is K971485.

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

URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) received FDA 510(k) clearance on 1997-05-27, under 510(k) number K971485.

Who is the listed applicant for URIC ACID - 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 URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)?

The FDA product code for URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is CDO.

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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: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK955752OLYMPUS URIC ACID REAGENTOlympus America, 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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