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FDA 510(k)

BINDAZYME CLQ CIC EIA KIT

K-Number: K031563 · 2003-09-10

ApplicantThe Binding Site, Ltd.
Decision Date2003-09-10
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BINDAZYME CLQ CIC EIA 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 2003-09-10 under 510(k) number K031563. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINDAZYME CLQ CIC EIA KIT?

BINDAZYME CLQ CIC EIA KIT is a medical device that received FDA 510(k) clearance on 2003-09-10. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K031563.

When did BINDAZYME CLQ CIC EIA KIT receive FDA 510(k) clearance?

BINDAZYME CLQ CIC EIA KIT received FDA 510(k) clearance on 2003-09-10, under 510(k) number K031563.

Who is the listed applicant for BINDAZYME CLQ CIC EIA 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 BINDAZYME CLQ CIC EIA KIT?

The FDA product code for BINDAZYME CLQ CIC EIA KIT is DAK.

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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: DAK)

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.

K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K914388C1 RID KITThe Binding Site, 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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