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FDA 510(k)

AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K-Number: K972297 · 1997-07-17

ApplicantTrace America, Inc.
Decision Date1997-07-17
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE-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 1997-07-17 under 510(k) number K972297. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Trace America, Inc.. The 510(k) number is K972297.

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

AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) received FDA 510(k) clearance on 1997-07-17, under 510(k) number K972297.

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

The FDA product code for AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) is JFJ.

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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)

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Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, 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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