FDA 510(k)

ORTHO AUTOMATED CELL COUNTER

K-Number: K801545 · 1980-09-09

Decision Date1980-09-09

Product CodeGKL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ORTHO AUTOMATED CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Instruments. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801545. 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 ORTHO AUTOMATED CELL COUNTER?

ORTHO AUTOMATED CELL COUNTER is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Ortho Instruments. The 510(k) number is K801545.

When did ORTHO AUTOMATED CELL COUNTER receive FDA 510(k) clearance?

ORTHO AUTOMATED CELL COUNTER received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801545.

Who is the listed applicant for ORTHO AUTOMATED CELL COUNTER?

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

What is the FDA product code for ORTHO AUTOMATED CELL COUNTER?

The FDA product code for ORTHO AUTOMATED CELL COUNTER is GKL.

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Other records listing Ortho Instruments as applicant

K803083ORTHO HEMOTOLOGY CONTROL-NORMAL K803073ORTHO HEMATOLOGY CONTROL K803084ORTHO HEMATOLOGY CONTROL ABNORMAL LOW K802094ORTHO SPECTRUM K781146HEMAC LASER HEMATOLOGY SYSTEM

Related Devices (Code: GKL)

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris Diagnostics K071652HEMOCUE WBC SYSTEMHemocue AB K051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLC K050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.