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FDA 510(k)

CO2 CALIBRATOR/DILUENT

K-Number: K033643 · 2004-01-08

ApplicantBayer Healthcare, Diagnostics Division
Decision Date2004-01-08
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CO2 CALIBRATOR/DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, Diagnostics Division. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K033643. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 CALIBRATOR/DILUENT?

CO2 CALIBRATOR/DILUENT is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Bayer Healthcare, Diagnostics Division. The 510(k) number is K033643.

When did CO2 CALIBRATOR/DILUENT receive FDA 510(k) clearance?

CO2 CALIBRATOR/DILUENT received FDA 510(k) clearance on 2004-01-08, under 510(k) number K033643.

Who is the listed applicant for CO2 CALIBRATOR/DILUENT?

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

What is the FDA product code for CO2 CALIBRATOR/DILUENT?

The FDA product code for CO2 CALIBRATOR/DILUENT is JIT.

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Other records listing Bayer Healthcare, Diagnostics Division 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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