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FDA 510(k)

Atellica CH Amylase_2 (AMY_2)

K-Number: K191454 · 2019-07-30

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-07-30
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica CH Amylase_2 (AMY_2) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K191454. 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 Atellica CH Amylase_2 (AMY_2)?

Atellica CH Amylase_2 (AMY_2) is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K191454.

When did Atellica CH Amylase_2 (AMY_2) receive FDA 510(k) clearance?

Atellica CH Amylase_2 (AMY_2) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191454.

Who is the listed applicant for Atellica CH Amylase_2 (AMY_2)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica CH Amylase_2 (AMY_2)?

The FDA product code for Atellica CH Amylase_2 (AMY_2) is JFJ.

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

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K253528Atellica IM CA 19-9 IIPMA P930027Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P010007KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK261364Atellica CH Acetaminophen 2 (ACTM)PMA P930036KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P250026Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

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Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK182474alpha-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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