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)

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)

K-Number: K955380 · 1996-05-14

ApplicantInternational Biophysics Corp.
Decision Date1996-05-14
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corp.. It received FDA 510(k) clearance on 1996-05-14 under 510(k) number K955380. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)?

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) is a medical device that received FDA 510(k) clearance on 1996-05-14. The listed applicant is International Biophysics Corp.. The 510(k) number is K955380.

When did IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) receive FDA 510(k) clearance?

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) received FDA 510(k) clearance on 1996-05-14, under 510(k) number K955380.

Who is the listed applicant for IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)?

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

What is the FDA product code for IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)?

The FDA product code for IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) is DRY.

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 International Biophysics Corp. 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.

K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEMK992657IBC VRV, MODEL 1350K992785IBC FLOGUARD, MODEL 6050K992964IBC VENT VALVE, MODEL 1400K983272IBC FLOPUMP, MODEL 6000

View all 11 devices →

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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.

↑