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FDA 510(k)

COULTER COUNTER MODEL M4

K-Number: K843303 · 1984-12-05

ApplicantCoulter Electronics, Inc.
Decision Date1984-12-05
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER COUNTER MODEL M4 is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1984-12-05 under 510(k) number K843303. 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 COULTER COUNTER MODEL M4?

COULTER COUNTER MODEL M4 is a medical device that received FDA 510(k) clearance on 1984-12-05. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K843303.

When did COULTER COUNTER MODEL M4 receive FDA 510(k) clearance?

COULTER COUNTER MODEL M4 received FDA 510(k) clearance on 1984-12-05, under 510(k) number K843303.

Who is the listed applicant for COULTER COUNTER MODEL M4?

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

What is the FDA product code for COULTER COUNTER MODEL M4?

The FDA product code for COULTER COUNTER MODEL M4 is GKL.

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Other records listing Coulter Electronics, 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.K032677SYSMEX POCH-100ISysmex America, Inc.

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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