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FDA 510(k)

TRACE MICROPROTEIN REAGENT

K-Number: K925794 · 1993-03-29

ApplicantTrace America, Inc.
Decision Date1993-03-29
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE MICROPROTEIN REAGENT 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 1993-03-29 under 510(k) number K925794. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACE MICROPROTEIN REAGENT?

TRACE MICROPROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1993-03-29. The listed applicant is Trace America, Inc.. The 510(k) number is K925794.

When did TRACE MICROPROTEIN REAGENT receive FDA 510(k) clearance?

TRACE MICROPROTEIN REAGENT received FDA 510(k) clearance on 1993-03-29, under 510(k) number K925794.

Who is the listed applicant for TRACE MICROPROTEIN REAGENT?

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 TRACE MICROPROTEIN REAGENT?

The FDA product code for TRACE MICROPROTEIN REAGENT is JGQ.

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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: JGQ)

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.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K071239TOTAL PROTEIN URINE/CSF GEN.3Roche DiagnosticsK981295UPROAbbott LaboratoriesK981682UPROAbbott LaboratoriesK913615URINARY/CSF PROTEINBoehringer Mannheim Corp.

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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