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FDA 510(k)

IVOS ANALYZER

K-Number: K920719 · 1992-06-29

ApplicantHamilton Thorne Research
Decision Date1992-06-29
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IVOS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Research. It received FDA 510(k) clearance on 1992-06-29 under 510(k) number K920719. 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 IVOS ANALYZER?

IVOS ANALYZER is a medical device that received FDA 510(k) clearance on 1992-06-29. The listed applicant is Hamilton Thorne Research. The 510(k) number is K920719.

When did IVOS ANALYZER receive FDA 510(k) clearance?

IVOS ANALYZER received FDA 510(k) clearance on 1992-06-29, under 510(k) number K920719.

Who is the listed applicant for IVOS ANALYZER?

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

What is the FDA product code for IVOS ANALYZER?

The FDA product code for IVOS ANALYZER 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 Hamilton Thorne Research 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.

K012805AUTOMARQERK000380FOTOMASTERK990184AUTOMARQERK873172HAMILTON-THORN MOTILITY ANALYZER HTM-2000

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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