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FDA 510(k)

LD1 ISOENZYME REAGENT KIT

K-Number: K890996 · 1989-05-05

ApplicantTrace Scientific , Ltd.
Decision Date1989-05-05
Product CodeJGF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LD1 ISOENZYME REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K890996. The device is classified under product code JGF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LD1 ISOENZYME REAGENT KIT?

LD1 ISOENZYME REAGENT KIT is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K890996.

When did LD1 ISOENZYME REAGENT KIT receive FDA 510(k) clearance?

LD1 ISOENZYME REAGENT KIT received FDA 510(k) clearance on 1989-05-05, under 510(k) number K890996.

Who is the listed applicant for LD1 ISOENZYME REAGENT KIT?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LD1 ISOENZYME REAGENT KIT?

The FDA product code for LD1 ISOENZYME REAGENT KIT is JGF.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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Related Devices (Code: JGF)

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.

K981338LD-1Abbott LaboratoriesK925188ABBOTT QUICKSTART LD-1, MODIFICATIONEm Diagnostic Systems, Inc.K914261ABBOTT QUICKSTART LD-1,#5A30Em Diagnostic Systems, Inc.K871240ABBOTT A-GENT LD-1 ISOZYME REAGENTAbbott LaboratoriesK860367MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)Alpkem 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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