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FDA 510(k)

HICHEM BUN/UREA REAGENT KIT

K-Number: K960115 · 1996-03-29

ApplicantElan Pharma, Inc.
Decision Date1996-03-29
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM BUN/UREA REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Pharma, Inc.. It received FDA 510(k) clearance on 1996-03-29 under 510(k) number K960115. 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 HICHEM BUN/UREA REAGENT KIT?

HICHEM BUN/UREA REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Elan Pharma, Inc.. The 510(k) number is K960115.

When did HICHEM BUN/UREA REAGENT KIT receive FDA 510(k) clearance?

HICHEM BUN/UREA REAGENT KIT received FDA 510(k) clearance on 1996-03-29, under 510(k) number K960115.

Who is the listed applicant for HICHEM BUN/UREA REAGENT KIT?

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

What is the FDA product code for HICHEM BUN/UREA REAGENT KIT?

The FDA product code for HICHEM BUN/UREA REAGENT KIT is CDQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Elan Pharma, Inc. 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.

K982469HICHEM CHOLESTEROL REAGENT KITK981769HICHEM PHOSPHORUS REAGENT KITK962247HICHEM CK/NAC REAGENT KIT

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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