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FDA 510(k)

BUN TEST UNI-UV BLOOD UREA NITROGEN TEST

K-Number: K780943 · 1978-07-27

ApplicantSclavo, Inc.
Decision Date1978-07-27
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN TEST UNI-UV BLOOD UREA NITROGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780943. 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 BUN TEST UNI-UV BLOOD UREA NITROGEN TEST?

BUN TEST UNI-UV BLOOD UREA NITROGEN TEST is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Sclavo, Inc.. The 510(k) number is K780943.

When did BUN TEST UNI-UV BLOOD UREA NITROGEN TEST receive FDA 510(k) clearance?

BUN TEST UNI-UV BLOOD UREA NITROGEN TEST received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780943.

Who is the listed applicant for BUN TEST UNI-UV BLOOD UREA NITROGEN TEST?

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

What is the FDA product code for BUN TEST UNI-UV BLOOD UREA NITROGEN TEST?

The FDA product code for BUN TEST UNI-UV BLOOD UREA NITROGEN TEST is CDQ.

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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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