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FDA 510(k)

DATA-ZYME UREA NITROGEN REAGENT SET

K-Number: K802061 · 1980-09-26

ApplicantData Medical Associates, Inc.
Decision Date1980-09-26
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME UREA NITROGEN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802061. 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 DATA-ZYME UREA NITROGEN REAGENT SET?

DATA-ZYME UREA NITROGEN REAGENT SET is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K802061.

When did DATA-ZYME UREA NITROGEN REAGENT SET receive FDA 510(k) clearance?

DATA-ZYME UREA NITROGEN REAGENT SET received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802061.

Who is the listed applicant for DATA-ZYME UREA NITROGEN REAGENT SET?

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

What is the FDA product code for DATA-ZYME UREA NITROGEN REAGENT SET?

The FDA product code for DATA-ZYME UREA NITROGEN REAGENT SET is CDQ.

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Other records listing Data Medical Associates, 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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