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FDA 510(k)

ALBUMIN REAGENT SET

K-Number: K821193 · 1982-07-13

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

Device Summary

ALBUMIN 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 K821193. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN REAGENT SET?

ALBUMIN 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 K821193.

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

ALBUMIN REAGENT SET received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821193.

Who is the listed applicant for ALBUMIN 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 ALBUMIN REAGENT SET?

The FDA product code for ALBUMIN REAGENT SET is CIX.

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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

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Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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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