FDA 510(k)

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

K-Number: K031644 · 2003-06-25

Decision Date2003-06-25

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY 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 2003-06-25 under 510(k) number K031644. 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 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL?

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K031644.

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

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL received FDA 510(k) clearance on 2003-06-25, under 510(k) number K031644.

Who is the listed applicant for BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY 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 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL?

The FDA product code for BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL is 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.