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FDA 510(k)

UREA ASSAY KIT

K-Number: K842242 · 1984-07-18

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-07-18
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA 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 1984-07-18 under 510(k) number K842242. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA ASSAY KIT?

UREA ASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-07-18. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K842242.

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

UREA ASSAY KIT received FDA 510(k) clearance on 1984-07-18, under 510(k) number K842242.

Who is the listed applicant for UREA 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 UREA ASSAY KIT?

The FDA product code for UREA ASSAY KIT is CDQ.

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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: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, Inc.

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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