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FDA 510(k)

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

K-Number: K852589 · 1985-07-15

ApplicantAbbott Laboratories
Decision Date1985-07-15
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K852589. 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 TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT?

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Abbott Laboratories. The 510(k) number is K852589.

When did TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT receive FDA 510(k) clearance?

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT received FDA 510(k) clearance on 1985-07-15, under 510(k) number K852589.

Who is the listed applicant for TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT?

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 TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT?

The FDA product code for TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT 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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