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FDA 510(k)

UREA NITROGEN (BUN) LIQUID REAGENT

K-Number: K011596 · 2001-07-17

ApplicantJas Diagnostic, Inc.
Decision Date2001-07-17
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN (BUN) LIQUID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostic, Inc.. It received FDA 510(k) clearance on 2001-07-17 under 510(k) number K011596. 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 NITROGEN (BUN) LIQUID REAGENT?

UREA NITROGEN (BUN) LIQUID REAGENT is a medical device that received FDA 510(k) clearance on 2001-07-17. The listed applicant is Jas Diagnostic, Inc.. The 510(k) number is K011596.

When did UREA NITROGEN (BUN) LIQUID REAGENT receive FDA 510(k) clearance?

UREA NITROGEN (BUN) LIQUID REAGENT received FDA 510(k) clearance on 2001-07-17, under 510(k) number K011596.

Who is the listed applicant for UREA NITROGEN (BUN) LIQUID REAGENT?

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

What is the FDA product code for UREA NITROGEN (BUN) LIQUID REAGENT?

The FDA product code for UREA NITROGEN (BUN) LIQUID REAGENT is CDQ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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