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FDA 510(k)

IGA

K-Number: K983359 · 1998-11-04

ApplicantAbbott Laboratories
Decision Date1998-11-04
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGA is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K983359. 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 IGA?

IGA is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Abbott Laboratories. The 510(k) number is K983359.

When did IGA receive FDA 510(k) clearance?

IGA received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983359.

Who is the listed applicant for IGA?

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

What is the FDA product code for IGA?

The FDA product code for IGA is CZP.

Related PubMed Literature

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.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 42324971Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.Expert review of medical devices ()PMID: 42180407Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities.Frontiers in drug safety and regulation ()PMID: 41839575A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery ()

Other records listing Abbott Laboratories 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.

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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.K962200QUANTEX IGAInstrumentation Laboratory CO

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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