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FDA 510(k)

UREA/BUN, SCAL, NORTROL, ABTROL

K-Number: K073295 · 2008-05-29

ApplicantThermofisher Scientific OY
Decision Date2008-05-29
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA/BUN, SCAL, NORTROL, ABTROL is the device name listed in this FDA 510(k) record. The listed applicant is Thermofisher Scientific OY. It received FDA 510(k) clearance on 2008-05-29 under 510(k) number K073295. 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/BUN, SCAL, NORTROL, ABTROL?

UREA/BUN, SCAL, NORTROL, ABTROL is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Thermofisher Scientific OY. The 510(k) number is K073295.

When did UREA/BUN, SCAL, NORTROL, ABTROL receive FDA 510(k) clearance?

UREA/BUN, SCAL, NORTROL, ABTROL received FDA 510(k) clearance on 2008-05-29, under 510(k) number K073295.

Who is the listed applicant for UREA/BUN, SCAL, NORTROL, ABTROL?

The FDA 510(k) record lists Thermofisher Scientific OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA/BUN, SCAL, NORTROL, ABTROL?

The FDA product code for UREA/BUN, SCAL, NORTROL, ABTROL is CDQ.

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Other records listing Thermofisher Scientific OY 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.

K110035INDIKOK073612URIC ACID (AOX), SCAL, NORTROL, ABTROLK073191ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROLK073355CALCIUM, SCAL, NORTROL, ABTROLK070824CREATININE (ENZYMATIC)K071340CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

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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.K070146ABX 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.K024182PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTSPrecision Systems, 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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