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FDA 510(k)

IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS

K-Number: K982100 · 1999-12-20

ApplicantThe Binding Site, Ltd.
Decision Date1999-12-20
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS 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 1999-12-20 under 510(k) number K982100. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS?

IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K982100.

When did IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS receive FDA 510(k) clearance?

IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS received FDA 510(k) clearance on 1999-12-20, under 510(k) number K982100.

Who is the listed applicant for IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS?

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 IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS?

The FDA product code for IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS is CFN.

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Other records listing The Binding Site, Ltd. 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.

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: CFN)

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.

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbHK221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.

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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