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FDA 510(k)

IL TEST(TM) UREA NITROGEN

K-Number: K914877 · 1992-03-11

ApplicantInstrumentation Laboratory CO
Decision Date1992-03-11
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST(TM) UREA NITROGEN is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K914877. 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 IL TEST(TM) UREA NITROGEN?

IL TEST(TM) UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K914877.

When did IL TEST(TM) UREA NITROGEN receive FDA 510(k) clearance?

IL TEST(TM) UREA NITROGEN received FDA 510(k) clearance on 1992-03-11, under 510(k) number K914877.

Who is the listed applicant for IL TEST(TM) UREA NITROGEN?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST(TM) UREA NITROGEN?

The FDA product code for IL TEST(TM) UREA NITROGEN is CDQ.

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Other records listing Instrumentation Laboratory CO 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.

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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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