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FDA 510(k)

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

K-Number: K020979 · 2002-06-27

ApplicantDade Behring, Inc.
Decision Date2002-06-27
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 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 2002-06-27 under 510(k) number K020979. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000?

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 is a medical device that received FDA 510(k) clearance on 2002-06-27. The listed applicant is Dade Behring, Inc.. The 510(k) number is K020979.

When did SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 receive FDA 510(k) clearance?

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 received FDA 510(k) clearance on 2002-06-27, under 510(k) number K020979.

Who is the listed applicant for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000?

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 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000?

The FDA product code for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 is GKP.

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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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