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FDA 510(k)

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT

K-Number: K984165 · 1999-02-02

ApplicantThe Binding Site, Ltd.
Decision Date1999-02-02
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K984165. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT?

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K984165.

When did ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 1999-02-02, under 510(k) number K984165.

Who is the listed applicant for ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT?

The FDA 510(k) record lists The Binding Site, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT?

The FDA product code for ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT is JZO.

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Other records listing The Binding Site, Ltd. as applicant

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K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KITK082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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Related Devices (Code: JZO)

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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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