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FDA 510(k)

CLINITEK ADVANTUS, MODEL 1420

K-Number: K063276 · 2006-12-28

ApplicantBayer Healthcare, LLC
Decision Date2006-12-28
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINITEK ADVANTUS, MODEL 1420 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 2006-12-28 under 510(k) number K063276. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINITEK ADVANTUS, MODEL 1420?

CLINITEK ADVANTUS, MODEL 1420 is a medical device that received FDA 510(k) clearance on 2006-12-28. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K063276.

When did CLINITEK ADVANTUS, MODEL 1420 receive FDA 510(k) clearance?

CLINITEK ADVANTUS, MODEL 1420 received FDA 510(k) clearance on 2006-12-28, under 510(k) number K063276.

Who is the listed applicant for CLINITEK ADVANTUS, MODEL 1420?

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 CLINITEK ADVANTUS, MODEL 1420?

The FDA product code for CLINITEK ADVANTUS, MODEL 1420 is JIL.

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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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