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FDA 510(k)

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

K-Number: K993299 · 1999-12-07

ApplicantDade Behring, Inc.
Decision Date1999-12-07
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 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 1999-12-07 under 510(k) number K993299. 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-1500?

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 is a medical device that received FDA 510(k) clearance on 1999-12-07. The listed applicant is Dade Behring, Inc.. The 510(k) number is K993299.

When did SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 receive FDA 510(k) clearance?

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 received FDA 510(k) clearance on 1999-12-07, under 510(k) number K993299.

Who is the listed applicant for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500?

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-1500?

The FDA product code for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 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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