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FDA 510(k)

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)

K-Number: K875346 · 1988-04-07

ApplicantContraves Medical Instruments, Inc.
Decision Date1988-04-07
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) is the device name listed in this FDA 510(k) record. The listed applicant is Contraves Medical Instruments, Inc.. It received FDA 510(k) clearance on 1988-04-07 under 510(k) number K875346. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)?

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Contraves Medical Instruments, Inc.. The 510(k) number is K875346.

When did AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) receive FDA 510(k) clearance?

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) received FDA 510(k) clearance on 1988-04-07, under 510(k) number K875346.

Who is the listed applicant for AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)?

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

What is the FDA product code for AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)?

The FDA product code for AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) is GKZ.

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 Contraves Medical Instruments, Inc. 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.

K873252DIGICELL 500K873271DIGICELL 300 SYSTEM

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex 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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