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FDA 510(k)

Amylase2

K-Number: K210633 · 2022-05-26

ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-05-26
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Amylase2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-05-26 under approval number K210633. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amylase2?

Amylase2 is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K210633.

When was Amylase2 approved by the FDA?

Amylase2 received FDA 510(k) clearance on 2022-05-26, under approval number K210633.

What company makes Amylase2?

Amylase2 is manufactured by Abbott Ireland Diagnostics Division.

What is the FDA product code for Amylase2?

The FDA product code for Amylase2 is JFJ.

Other Devices by Abbott Ireland Diagnostics Division

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Related Devices (Code: JFJ)

K191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc. K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems 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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