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FDA 510(k)

ISOTONIC DILUENT

K-Number: K790442 · 1979-04-04

ApplicantRoyco Instruments
Decision Date1979-04-04
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ISOTONIC DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Royco Instruments. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K790442. 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 ISOTONIC DILUENT?

ISOTONIC DILUENT is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Royco Instruments. The 510(k) number is K790442.

When did ISOTONIC DILUENT receive FDA 510(k) clearance?

ISOTONIC DILUENT received FDA 510(k) clearance on 1979-04-04, under 510(k) number K790442.

Who is the listed applicant for ISOTONIC DILUENT?

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

What is the FDA product code for ISOTONIC DILUENT?

The FDA product code for ISOTONIC 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 Royco Instruments 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.

K800104ROYCO MODEL 951 CELL MIXERK791867ROYCO MODEL 921 CELL COUNTERK791644ROYCO MODEL 371 SUPER DILUTOR

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.

K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K883989KVM ISOTONIC FLUSH SOLUTIONKvm 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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