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FDA 510(k)

URIC ACID REAGENT SET

K-Number: K821213 · 1982-07-13

ApplicantOmega Medical Electronics
Decision Date1982-07-13
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID 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 1982-07-13 under 510(k) number K821213. The device is classified under product code CDH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID REAGENT SET?

URIC ACID REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Omega Medical Electronics. The 510(k) number is K821213.

When did URIC ACID REAGENT SET receive FDA 510(k) clearance?

URIC ACID REAGENT SET received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821213.

Who is the listed applicant for URIC ACID 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 URIC ACID REAGENT SET?

The FDA product code for URIC ACID REAGENT SET is CDH.

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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 SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

View all 21 devices →

Related Devices (Code: CDH)

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.

K850933URIC ACIDDilab, Inc.K841067URIC ACID REAGENT SETMedical Specialties, Inc.K813076PHOSPHOTUNGSTATE REDUCTION, URIC ACIDAmerican Monitor Corp.K810088URIC ACID (TPTZ) COLORINMETRICBio-Analytics Laboratories, Inc.K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-ACDiagnostic Solutions, Inc.K800190STANBIO DIRECT URIC ACID TEST SET #0770Stanbio Laboratory

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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