Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM

K-Number: K061392 · 2006-08-01

ApplicantIkonisys, Inc.
Decision Date2006-08-01
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ikonisys, Inc.. It received FDA 510(k) clearance on 2006-08-01 under 510(k) number K061392. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM?

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-01. The listed applicant is Ikonisys, Inc.. The 510(k) number is K061392.

When did IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM receive FDA 510(k) clearance?

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM received FDA 510(k) clearance on 2006-08-01, under 510(k) number K061392.

Who is the listed applicant for IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM?

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

What is the FDA product code for IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM?

The FDA product code for IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM is JOY.

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 Ikonisys, 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.

K080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000K062755IKONISCOPE ONCOFISH BLADDER TEST SYSTEMK052577IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM

Related Devices (Code: JOY)

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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex 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.

↑