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FDA 510(k)

DATA-ZYME UREA NITROGEN, COLORIMETRIC

K-Number: K801727 · 1980-09-09

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

Device Summary

DATA-ZYME UREA NITROGEN, COLORIMETRIC 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 1980-09-09 under 510(k) number K801727. The device is classified under product code CDL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-ZYME UREA NITROGEN, COLORIMETRIC?

DATA-ZYME UREA NITROGEN, COLORIMETRIC is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K801727.

When did DATA-ZYME UREA NITROGEN, COLORIMETRIC receive FDA 510(k) clearance?

DATA-ZYME UREA NITROGEN, COLORIMETRIC received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801727.

Who is the listed applicant for DATA-ZYME UREA NITROGEN, COLORIMETRIC?

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, COLORIMETRIC?

The FDA product code for DATA-ZYME UREA NITROGEN, COLORIMETRIC is CDL.

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Other records listing Data Medical Associates, Inc. as applicant

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Related Devices (Code: CDL)

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.

K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTReagents Applications, Inc.K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.

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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