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FDA 510(k)

WIENER LAB. UREA UV CINETICA AA

K-Number: K012260 · 2001-09-19

ApplicantWiener Laboratories Saic
Decision Date2001-09-19
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB. UREA UV CINETICA AA is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012260. 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 WIENER LAB. UREA UV CINETICA AA?

WIENER LAB. UREA UV CINETICA AA is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K012260.

When did WIENER LAB. UREA UV CINETICA AA receive FDA 510(k) clearance?

WIENER LAB. UREA UV CINETICA AA received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012260.

Who is the listed applicant for WIENER LAB. UREA UV CINETICA AA?

The FDA 510(k) record lists Wiener Laboratories Saic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIENER LAB. UREA UV CINETICA AA?

The FDA product code for WIENER LAB. UREA UV CINETICA AA is CDQ.

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Other records listing Wiener Laboratories Saic 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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