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FDA 510(k)

BAYER RAPIDPOINT 405 SYSTEM

K-Number: K020616 · 2002-07-17

ApplicantBayer Diagnostics Corp.
Decision Date2002-07-17
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BAYER RAPIDPOINT 405 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2002-07-17 under 510(k) number K020616. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER RAPIDPOINT 405 SYSTEM?

BAYER RAPIDPOINT 405 SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-17. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K020616.

When did BAYER RAPIDPOINT 405 SYSTEM receive FDA 510(k) clearance?

BAYER RAPIDPOINT 405 SYSTEM received FDA 510(k) clearance on 2002-07-17, under 510(k) number K020616.

Who is the listed applicant for BAYER RAPIDPOINT 405 SYSTEM?

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

What is the FDA product code for BAYER RAPIDPOINT 405 SYSTEM?

The FDA product code for BAYER RAPIDPOINT 405 SYSTEM is GKR.

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Other records listing Bayer Diagnostics Corp. as applicant

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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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