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FDA 510(k)

SYSMEX CA-1000/SYSMEX CA-5000

K-Number: K964946 · 1997-03-18

ApplicantSysmex Corp.
Decision Date1997-03-18
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX CA-1000/SYSMEX CA-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K964946. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX CA-1000/SYSMEX CA-5000?

SYSMEX CA-1000/SYSMEX CA-5000 is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Sysmex Corp.. The 510(k) number is K964946.

When did SYSMEX CA-1000/SYSMEX CA-5000 receive FDA 510(k) clearance?

SYSMEX CA-1000/SYSMEX CA-5000 received FDA 510(k) clearance on 1997-03-18, under 510(k) number K964946.

Who is the listed applicant for SYSMEX CA-1000/SYSMEX CA-5000?

The FDA 510(k) record lists Sysmex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSMEX CA-1000/SYSMEX CA-5000?

The FDA product code for SYSMEX CA-1000/SYSMEX CA-5000 is JPA.

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Other records listing Sysmex Corp. 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.

K012372SYSMEX UF-50K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERK981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERK971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERK964375SYSMEX SE/RAM-1

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Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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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