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FDA 510(k)

ORTHO SPECTRUM

K-Number: K802094 · 1980-10-10

ApplicantOrtho Instruments
Decision Date1980-10-10
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO SPECTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Instruments. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802094. 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 SPECTRUM?

ORTHO SPECTRUM is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Ortho Instruments. The 510(k) number is K802094.

When did ORTHO SPECTRUM receive FDA 510(k) clearance?

ORTHO SPECTRUM received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802094.

Who is the listed applicant for ORTHO SPECTRUM?

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 SPECTRUM?

The FDA product code for ORTHO SPECTRUM is GKL.

Related Clinical Trials

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.

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Other records listing Ortho Instruments 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.

K803083ORTHO HEMOTOLOGY CONTROL-NORMALK803073ORTHO HEMATOLOGY CONTROLK803084ORTHO HEMATOLOGY CONTROL ABNORMAL LOWK801545ORTHO AUTOMATED CELL COUNTERK781146HEMAC LASER HEMATOLOGY SYSTEM

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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