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FDA 510(k)

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

K-Number: K980032 · 1998-03-02

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-03-02
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K980032. 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 SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71?

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K980032.

When did SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 receive FDA 510(k) clearance?

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 received FDA 510(k) clearance on 1998-03-02, under 510(k) number K980032.

Who is the listed applicant for SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71?

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

What is the FDA product code for SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71?

The FDA product code for SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 is DKJ.

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Other records listing Diagnostic Chemicals , 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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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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