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FDA 510(k)

EASYTOUCH BUN REAGENT SET

K-Number: K832749 · 1983-10-14

ApplicantWorthington Diagnostic Systems
Decision Date1983-10-14
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYTOUCH BUN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832749. 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 EASYTOUCH BUN REAGENT SET?

EASYTOUCH BUN REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K832749.

When did EASYTOUCH BUN REAGENT SET receive FDA 510(k) clearance?

EASYTOUCH BUN REAGENT SET received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832749.

Who is the listed applicant for EASYTOUCH BUN REAGENT SET?

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

What is the FDA product code for EASYTOUCH BUN REAGENT SET?

The FDA product code for EASYTOUCH BUN REAGENT SET is CDQ.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832427EASYTOUCH TROMBOPLASTIN REAGENTK832750EASYTOUCH HEMOGLOBIN REAGENTK832426EASYTOUCH TRIGLYCERIDES REAGENT SET

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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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