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FDA 510(k)

QUANTEX IGG

K-Number: K962202 · 1996-09-26

ApplicantInstrumentation Laboratory CO
Decision Date1996-09-26
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTEX IGG 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 1996-09-26 under 510(k) number K962202. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTEX IGG?

QUANTEX IGG is a medical device that received FDA 510(k) clearance on 1996-09-26. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K962202.

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

QUANTEX IGG received FDA 510(k) clearance on 1996-09-26, under 510(k) number K962202.

Who is the listed applicant for QUANTEX IGG?

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 IGG?

The FDA product code for QUANTEX IGG is DEW.

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott 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.

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