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FDA 510(k)

ORTHO ELT-8/DS HEMATOLOGY ANALYZER

K-Number: K833618 · 1984-01-13

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1984-01-13
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO ELT-8/DS HEMATOLOGY ANALYZER 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 1984-01-13 under 510(k) number K833618. 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 ORTHO ELT-8/DS HEMATOLOGY ANALYZER?

ORTHO ELT-8/DS HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K833618.

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

ORTHO ELT-8/DS HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833618.

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

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 ORTHO ELT-8/DS HEMATOLOGY ANALYZER?

The FDA product code for ORTHO ELT-8/DS HEMATOLOGY ANALYZER 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)

View all 126 devices →

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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