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FDA 510(k)

UREA NITROGEN (ENZYMATIC) DETERMINATION

K-Number: K822154 · 1982-08-05

ApplicantThe Dow Chemical Co.
Decision Date1982-08-05
Product CodeCDN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN (ENZYMATIC) DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1982-08-05 under 510(k) number K822154. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA NITROGEN (ENZYMATIC) DETERMINATION?

UREA NITROGEN (ENZYMATIC) DETERMINATION is a medical device that received FDA 510(k) clearance on 1982-08-05. The listed applicant is The Dow Chemical Co.. The 510(k) number is K822154.

When did UREA NITROGEN (ENZYMATIC) DETERMINATION receive FDA 510(k) clearance?

UREA NITROGEN (ENZYMATIC) DETERMINATION received FDA 510(k) clearance on 1982-08-05, under 510(k) number K822154.

Who is the listed applicant for UREA NITROGEN (ENZYMATIC) DETERMINATION?

The FDA 510(k) record lists The Dow Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA NITROGEN (ENZYMATIC) DETERMINATION?

The FDA product code for UREA NITROGEN (ENZYMATIC) DETERMINATION is CDN.

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Other records listing The Dow Chemical Co. 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATIONK812777DIRECT IRON REAGENT SET

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Related Devices (Code: CDN)

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.

K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.K132462S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREHitachi Chemical Diagnostics, Inc.K123322ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENTAlfa Wassermann Diagnostics Technologies, LLCK113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.K001885VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1Ortho-Clinical 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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