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FDA 510(k)

Albumin BCG2

K-Number: K203248 · 2021-11-23

ApplicantAbbott Ireland Diagnostics Division
Decision Date2021-11-23
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Albumin BCG2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K203248. 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 BCG2?

Albumin BCG2 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203248.

When did Albumin BCG2 receive FDA 510(k) clearance?

Albumin BCG2 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K203248.

Who is the listed applicant for Albumin BCG2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Albumin BCG2?

The FDA product code for Albumin BCG2 is CIX.

Other records listing Abbott Ireland Diagnostics Division 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.

K223317Alkaline Phosphatase2K223324Total Bilirubin2K203597Cholesterol2K203771Urea Nitrogen2K210633Amylase2K210452Creatinine2

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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 HealthK200898Medicon 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.

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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