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FDA 510(k)

CELLECT 8E AUTOMATED BLOOD CELL COUNTERS

K-Number: K862374 · 1986-09-04

ApplicantInstrumentation Laboratory CO
Decision Date1986-09-04
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLECT 8E AUTOMATED BLOOD CELL COUNTERS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1986-09-04 under 510(k) number K862374. 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 CELLECT 8E AUTOMATED BLOOD CELL COUNTERS?

CELLECT 8E AUTOMATED BLOOD CELL COUNTERS is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K862374.

When did CELLECT 8E AUTOMATED BLOOD CELL COUNTERS receive FDA 510(k) clearance?

CELLECT 8E AUTOMATED BLOOD CELL COUNTERS received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862374.

Who is the listed applicant for CELLECT 8E AUTOMATED BLOOD CELL COUNTERS?

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

What is the FDA product code for CELLECT 8E AUTOMATED BLOOD CELL COUNTERS?

The FDA product code for CELLECT 8E AUTOMATED BLOOD CELL COUNTERS is GKL.

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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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