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FDA 510(k)

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE

K-Number: K930247 · 1993-03-10

ApplicantThe Binding Site, Ltd.
Decision Date1993-03-10
Product CodeDHC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE 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 1993-03-10 under 510(k) number K930247. The device is classified under product code DHC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE?

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE is a medical device that received FDA 510(k) clearance on 1993-03-10. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K930247.

When did HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE receive FDA 510(k) clearance?

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE received FDA 510(k) clearance on 1993-03-10, under 510(k) number K930247.

Who is the listed applicant for HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE?

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 HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE?

The FDA product code for HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE is DHC.

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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: DHC)

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.

K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.K930421ELIAS DSDNA ABSElias U.S.A., Inc.K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, Inc.K872910IMMUNO/SLEImmunostics Co., 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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