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FDA 510(k)

GDS ENZYMATIC SALICYLATE REAGENT

K-Number: K882038 · 1988-06-24

ApplicantGds Technology, LLC
Decision Date1988-06-24
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GDS ENZYMATIC SALICYLATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology, LLC. It received FDA 510(k) clearance on 1988-06-24 under 510(k) number K882038. The device is classified under product code DKJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDS ENZYMATIC SALICYLATE REAGENT?

GDS ENZYMATIC SALICYLATE REAGENT is a medical device that received FDA 510(k) clearance on 1988-06-24. The listed applicant is Gds Technology, LLC. The 510(k) number is K882038.

When did GDS ENZYMATIC SALICYLATE REAGENT receive FDA 510(k) clearance?

GDS ENZYMATIC SALICYLATE REAGENT received FDA 510(k) clearance on 1988-06-24, under 510(k) number K882038.

Who is the listed applicant for GDS ENZYMATIC SALICYLATE REAGENT?

The FDA 510(k) record lists Gds Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GDS ENZYMATIC SALICYLATE REAGENT?

The FDA product code for GDS ENZYMATIC SALICYLATE REAGENT is DKJ.

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Other records listing Gds Technology, LLC 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.

K994073HEMOSITE TEST SYSTEMK992132CHOLESITE TEST SYSTEMK973649HEMOSITE TEST SYSTEMK971145GLUCOSITE TEST SYSTEMK911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONK880829GDS ENZYMATIC ACETAMINOPHEN REAGENT

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Related Devices (Code: DKJ)

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.

K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare DiagnosticsK042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.K020794SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.

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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