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FDA 510(k)

SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER

K-Number: K911626 · 1991-09-13

ApplicantSerono Baker Diagnostics System
Decision Date1991-09-13
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Serono Baker Diagnostics System. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K911626. 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 SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER?

SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Serono Baker Diagnostics System. The 510(k) number is K911626.

When did SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER receive FDA 510(k) clearance?

SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER received FDA 510(k) clearance on 1991-09-13, under 510(k) number K911626.

Who is the listed applicant for SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER?

The FDA 510(k) record lists Serono Baker Diagnostics System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER?

The FDA product code for SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER is GKZ.

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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

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

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