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FDA 510(k)

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5

K-Number: K920949 · 1992-05-15

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-05-15
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-05-15 under 510(k) number K920949. 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 SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5?

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 is a medical device that received FDA 510(k) clearance on 1992-05-15. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K920949.

When did SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 receive FDA 510(k) clearance?

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 received FDA 510(k) clearance on 1992-05-15, under 510(k) number K920949.

Who is the listed applicant for SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5?

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

What is the FDA product code for SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5?

The FDA product code for SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 is GKZ.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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

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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