FDA 510(k)

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

K-Number: K030804 · 2003-04-10

Decision Date2003-04-10

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR 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 2003-04-10 under 510(k) number K030804. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR?

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR is a medical device that received FDA 510(k) clearance on 2003-04-10. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K030804.

When did BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR receive FDA 510(k) clearance?

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR received FDA 510(k) clearance on 2003-04-10, under 510(k) number K030804.

Who is the listed applicant for BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR?

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 BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR?

The FDA product code for BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR is JIX.

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Related Devices (Code: JIX)

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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.