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FDA 510(k)

DILUENT

K-Number: K831617 · 1983-06-16

ApplicantOmega Medical Diagnostics
Decision Date1983-06-16
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Diagnostics. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831617. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILUENT?

DILUENT is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Omega Medical Diagnostics. The 510(k) number is K831617.

When did DILUENT receive FDA 510(k) clearance?

DILUENT received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831617.

Who is the listed applicant for DILUENT?

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

What is the FDA product code for DILUENT?

The FDA product code for DILUENT is GIF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omega Medical Diagnostics 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.

K832182LYSING REAGENTK831619SODIUM HYPOCHLORITE 7%K831620SODIUM HYPOCHLORITE 3%K831618HEMOGLOBIN REAGENT

Related Devices (Code: GIF)

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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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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