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FDA 510(k)

DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137

K-Number: K010208 · 2001-02-20

ApplicantDade Behring, Inc.
Decision Date2001-02-20
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-02-20 under 510(k) number K010208. 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 DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137?

DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 is a medical device that received FDA 510(k) clearance on 2001-02-20. The listed applicant is Dade Behring, Inc.. The 510(k) number is K010208.

When did DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 receive FDA 510(k) clearance?

DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 received FDA 510(k) clearance on 2001-02-20, under 510(k) number K010208.

Who is the listed applicant for DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137?

The FDA product code for DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 is JIT.

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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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