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FDA 510(k)

UREA NITROGEN REAGENT SET

K-Number: K821212 · 1982-07-22

ApplicantOmega Medical Electronics
Decision Date1982-07-22
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 Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821212. 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 1982-07-22. The listed applicant is Omega Medical Electronics. The 510(k) number is K821212.

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

UREA NITROGEN REAGENT SET received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821212.

Who is the listed applicant for UREA NITROGEN REAGENT SET?

The FDA 510(k) record lists Omega Medical Electronics 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 Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821206SGPT-UV REAGENT SETK821201LDH-UV REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

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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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