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FDA 510(k)

K.D. COLORIMETRIC BLOOD UREA N2 TEST

K-Number: K820418 · 1982-03-11

ApplicantKing Diagnostics, Inc.
Decision Date1982-03-11
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

K.D. COLORIMETRIC BLOOD UREA N2 TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820418. The device is classified under product code JGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K.D. COLORIMETRIC BLOOD UREA N2 TEST?

K.D. COLORIMETRIC BLOOD UREA N2 TEST is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K820418.

When did K.D. COLORIMETRIC BLOOD UREA N2 TEST receive FDA 510(k) clearance?

K.D. COLORIMETRIC BLOOD UREA N2 TEST received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820418.

Who is the listed applicant for K.D. COLORIMETRIC BLOOD UREA N2 TEST?

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

What is the FDA product code for K.D. COLORIMETRIC BLOOD UREA N2 TEST?

The FDA product code for K.D. COLORIMETRIC BLOOD UREA N2 TEST is JGZ.

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Other records listing King Diagnostics, Inc. as applicant

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K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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Related Devices (Code: JGZ)

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.

K904049ROCHE COBAS READY RENAL PROFILE REAGENT STRIPRoche Diagnostic Systems, Inc.K896236COBAS READY BUN REAGENTRoche Diagnostic Systems, Inc.K883327CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TESTHeraeus Kulzer, Inc.K863901IQ UREA NITROGENBd Becton Dickinson Vacutainer Systems PreanalyticK842772PHARMACIA B2-MICRO RIAPharmacia, Inc.K840213BLOOD UREA NITROGEN REAGENT SYSSclavo, 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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