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FDA 510(k)

UREA NITROGEN(BUN)

K-Number: K863925 · 1986-11-24

ApplicantTech-Co, Inc.
Decision Date1986-11-24
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN(BUN) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863925. 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)?

UREA NITROGEN(BUN) is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Tech-Co, Inc.. The 510(k) number is K863925.

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

UREA NITROGEN(BUN) received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863925.

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

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

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

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

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Other records listing Tech-Co, 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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