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FDA 510(k)

RAICHEM BUN RATE REAGENT

K-Number: K012649 · 2001-10-15

ApplicantHemagen Diagnostics, Inc.
Decision Date2001-10-15
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM BUN RATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K012649. 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 RAICHEM BUN RATE REAGENT?

RAICHEM BUN RATE REAGENT is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K012649.

When did RAICHEM BUN RATE REAGENT receive FDA 510(k) clearance?

RAICHEM BUN RATE REAGENT received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012649.

Who is the listed applicant for RAICHEM BUN RATE REAGENT?

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

What is the FDA product code for RAICHEM BUN RATE REAGENT?

The FDA product code for RAICHEM BUN RATE REAGENT is CDQ.

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Other records listing Hemagen Diagnostics, 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.

K041052RAICHEM GLUCOSE UV (LIQUID)K041051RAICHEM BUN RATE REAGENT (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

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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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