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FDA 510(k)

SYSMEX POCH-100I

K-Number: K032677 · 2004-02-11

ApplicantSysmex America, Inc.
Decision Date2004-02-11
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX POCH-100I is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2004-02-11 under 510(k) number K032677. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX POCH-100I?

SYSMEX POCH-100I is a medical device that received FDA 510(k) clearance on 2004-02-11. The listed applicant is Sysmex America, Inc.. The 510(k) number is K032677.

When did SYSMEX POCH-100I receive FDA 510(k) clearance?

SYSMEX POCH-100I received FDA 510(k) clearance on 2004-02-11, under 510(k) number K032677.

Who is the listed applicant for SYSMEX POCH-100I?

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

What is the FDA product code for SYSMEX POCH-100I?

The FDA product code for SYSMEX POCH-100I is GKL.

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Other records listing Sysmex America, Inc. as applicant

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Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K022331ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHODBayer Diagnostics Corp.

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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