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FDA 510(k)

SALICYLATE ASSAY KIT

K-Number: K842158 · 1984-10-22

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-10-22
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SALICYLATE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K842158. 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 KIT?

SALICYLATE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K842158.

When did SALICYLATE ASSAY KIT receive FDA 510(k) clearance?

SALICYLATE ASSAY KIT received FDA 510(k) clearance on 1984-10-22, under 510(k) number K842158.

Who is the listed applicant for SALICYLATE ASSAY KIT?

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

What is the FDA product code for SALICYLATE ASSAY KIT?

The FDA product code for SALICYLATE ASSAY KIT is DKJ.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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