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FDA 510(k)

AFINION ACR AND ACR CONTROL

K-Number: K072409 · 2008-02-12

ApplicantAxis-Shield Poc AS
Decision Date2008-02-12
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFINION ACR AND ACR CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Poc AS. It received FDA 510(k) clearance on 2008-02-12 under 510(k) number K072409. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFINION ACR AND ACR CONTROL?

AFINION ACR AND ACR CONTROL is a medical device that received FDA 510(k) clearance on 2008-02-12. The listed applicant is Axis-Shield Poc AS. The 510(k) number is K072409.

When did AFINION ACR AND ACR CONTROL receive FDA 510(k) clearance?

AFINION ACR AND ACR CONTROL received FDA 510(k) clearance on 2008-02-12, under 510(k) number K072409.

Who is the listed applicant for AFINION ACR AND ACR CONTROL?

The FDA 510(k) record lists Axis-Shield Poc AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFINION ACR AND ACR CONTROL?

The FDA product code for AFINION ACR AND ACR CONTROL is JFY.

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Other records listing Axis-Shield Poc AS 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.

K110056AFINION ANALYZERK050574AFINION HBALC

Related Devices (Code: JFY)

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.

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649Yumizen C1200 Creatinine PAPHORIBA ABX SASK182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation

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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