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FDA 510(k)

ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG

K-Number: K831271 · 1983-07-26

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1983-07-26
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831271. 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 ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG?

ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K831271.

When did ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG receive FDA 510(k) clearance?

ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831271.

Who is the listed applicant for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG?

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

What is the FDA product code for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG?

The FDA product code for ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG is GKZ.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

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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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