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FDA 510(k)

SYSMEX CA-6000

K-Number: K964139 · 1997-02-06

ApplicantDade Intl., Inc.
Decision Date1997-02-06
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX CA-6000 is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964139. 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 CA-6000?

SYSMEX CA-6000 is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Dade Intl., Inc.. The 510(k) number is K964139.

When did SYSMEX CA-6000 receive FDA 510(k) clearance?

SYSMEX CA-6000 received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964139.

Who is the listed applicant for SYSMEX CA-6000?

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

What is the FDA product code for SYSMEX CA-6000?

The FDA product code for SYSMEX CA-6000 is GKP.

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Other records listing Dade Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: 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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