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FDA 510(k)

Alkaline Phosphatase2

K-Number: K223317 · 2023-07-21

ApplicantAbbott Ireland Diagnostics Division
Decision Date2023-07-21
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alkaline Phosphatase2 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 2023-07-21 under 510(k) number K223317. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alkaline Phosphatase2?

Alkaline Phosphatase2 is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K223317.

When did Alkaline Phosphatase2 receive FDA 510(k) clearance?

Alkaline Phosphatase2 received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223317.

Who is the listed applicant for Alkaline Phosphatase2?

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 Alkaline Phosphatase2?

The FDA product code for Alkaline Phosphatase2 is CJE.

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.

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Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)Randox Laboratories Limited

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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