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FDA 510(k)

ROCHE REAGENT FOR BUN

K-Number: K954000 · 1995-10-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-10-25
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR BUN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-10-25 under 510(k) number K954000. 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 ROCHE REAGENT FOR BUN?

ROCHE REAGENT FOR BUN is a medical device that received FDA 510(k) clearance on 1995-10-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K954000.

When did ROCHE REAGENT FOR BUN receive FDA 510(k) clearance?

ROCHE REAGENT FOR BUN received FDA 510(k) clearance on 1995-10-25, under 510(k) number K954000.

Who is the listed applicant for ROCHE REAGENT FOR BUN?

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

What is the FDA product code for ROCHE REAGENT FOR BUN?

The FDA product code for ROCHE REAGENT FOR BUN is CDQ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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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