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FDA 510(k)

IGM

K-Number: K983132 · 1998-11-04

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

Device Summary

IGM 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 K983132. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGM?

IGM 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 K983132.

When did IGM receive FDA 510(k) clearance?

IGM received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983132.

Who is the listed applicant for IGM?

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 IGM?

The FDA product code for IGM is DFT.

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: 39022374Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order.Asian bioethics review ()PMID: 38528278The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today.Therapeutic innovation & regulatory science ()

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: DFT)

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.

K962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, Inc.K884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOrion Diagnostica, 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.

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