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)

QUANTEX IGA

K-Number: K962200 · 1996-09-25

ApplicantInstrumentation Laboratory CO
Decision Date1996-09-25
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTEX IGA is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1996-09-25 under 510(k) number K962200. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTEX IGA?

QUANTEX IGA is a medical device that received FDA 510(k) clearance on 1996-09-25. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K962200.

When did QUANTEX IGA receive FDA 510(k) clearance?

QUANTEX IGA received FDA 510(k) clearance on 1996-09-25, under 510(k) number K962200.

Who is the listed applicant for QUANTEX IGA?

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

What is the FDA product code for QUANTEX IGA?

The FDA product code for QUANTEX IGA is CZP.

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 Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

View all 315 devices →

Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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.

↑