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FDA 510(k)

DIRECT UREA NITROGEN TEST

K-Number: K780262 · 1978-04-05

ApplicantHycel, Inc.
Decision Date1978-04-05
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT UREA NITROGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1978-04-05 under 510(k) number K780262. 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 DIRECT UREA NITROGEN TEST?

DIRECT UREA NITROGEN TEST is a medical device that received FDA 510(k) clearance on 1978-04-05. The listed applicant is Hycel, Inc.. The 510(k) number is K780262.

When did DIRECT UREA NITROGEN TEST receive FDA 510(k) clearance?

DIRECT UREA NITROGEN TEST received FDA 510(k) clearance on 1978-04-05, under 510(k) number K780262.

Who is the listed applicant for DIRECT UREA NITROGEN TEST?

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

What is the FDA product code for DIRECT UREA NITROGEN TEST?

The FDA product code for DIRECT UREA NITROGEN TEST is CDW.

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Other records listing Hycel, Inc. as applicant

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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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Related Devices (Code: CDW)

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.

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.

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