FDA 510(k)

UREA NITROGEN REAGENT SET

K-Number: K813415 · 1981-12-31

Decision Date1981-12-31

Product CodeCDW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813415. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA NITROGEN REAGENT SET?

UREA NITROGEN REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K813415.

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

UREA NITROGEN REAGENT SET received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813415.

Who is the listed applicant for UREA NITROGEN REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for UREA NITROGEN REAGENT SET is CDW.

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Other records listing Anco Medical Reagents & Assoc. as applicant

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH K831871SICKLE-HEME A/S CONTROLS & A/A CONTROL K821658HEMOGLOBIN REAGENT K821526ACID PHOSPHATASE REAGENT SET K821102MEGNESIUM REAGENT KIT K820951ENZYMATIC CHOLESTEROL KIT

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Related Devices (Code: CDW)

K874532BLOOD UREA NITROGENCatachem, Inc.K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, 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.