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FDA 510(k)

ADVIA IMS CPSA CONTROL

K-Number: K061137 · 2006-07-06

ApplicantBayer Healthcare, LLC
Decision Date2006-07-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA IMS CPSA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2006-07-06 under 510(k) number K061137. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA IMS CPSA CONTROL?

ADVIA IMS CPSA CONTROL is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K061137.

When did ADVIA IMS CPSA CONTROL receive FDA 510(k) clearance?

ADVIA IMS CPSA CONTROL received FDA 510(k) clearance on 2006-07-06, under 510(k) number K061137.

Who is the listed applicant for ADVIA IMS CPSA CONTROL?

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

What is the FDA product code for ADVIA IMS CPSA CONTROL?

The FDA product code for ADVIA IMS CPSA CONTROL is JJY.

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Related Devices (Code: JJY)

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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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