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FDA 510(k)

DIMENSION ALDL CALIBRATOR, MODEL DC131

K-Number: K020723 · 2002-05-08

ApplicantDade Behring, Inc.
Decision Date2002-05-08
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION ALDL CALIBRATOR, MODEL DC131 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 2002-05-08 under 510(k) number K020723. 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 ALDL CALIBRATOR, MODEL DC131?

DIMENSION ALDL CALIBRATOR, MODEL DC131 is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Dade Behring, Inc.. The 510(k) number is K020723.

When did DIMENSION ALDL CALIBRATOR, MODEL DC131 receive FDA 510(k) clearance?

DIMENSION ALDL CALIBRATOR, MODEL DC131 received FDA 510(k) clearance on 2002-05-08, under 510(k) number K020723.

Who is the listed applicant for DIMENSION ALDL CALIBRATOR, MODEL DC131?

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 ALDL CALIBRATOR, MODEL DC131?

The FDA product code for DIMENSION ALDL CALIBRATOR, MODEL DC131 is JIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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