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FDA 510(k)

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

K-Number: K992399 · 1999-09-15

ApplicantBayer Corp.
Decision Date1999-09-15
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1999-09-15 under 510(k) number K992399. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-15. The listed applicant is Bayer Corp.. The 510(k) number is K992399.

When did ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM receive FDA 510(k) clearance?

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM received FDA 510(k) clearance on 1999-09-15, under 510(k) number K992399.

Who is the listed applicant for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

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

What is the FDA product code for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

The FDA product code for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM is CIX.

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Related Devices (Code: CIX)

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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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