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FDA 510(k)

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

K-Number: K123256 · 2013-07-03

ApplicantThe Binding Site Group , Ltd.
Decision Date2013-07-03
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K123256. The device is classified under product code DEM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS?

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K123256.

When did HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS receive FDA 510(k) clearance?

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS received FDA 510(k) clearance on 2013-07-03, under 510(k) number K123256.

Who is the listed applicant for HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS?

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

What is the FDA product code for HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS?

The FDA product code for HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS is DEM.

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Other records listing The Binding Site Group , 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.

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserK250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitK192116Human IgA liquid reagent kit for Use on SPAPlusK191985Optilite IgA KitK191635Optilite IgM KitK191465Human IgM Kit for use on SPAPlus

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Related Devices (Code: DEM)

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.

K063610DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K053072N ANTISERA TO HUMAN ALPHA1-ANTITRYPSINDade Behring, Inc.K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K050596QUANTIA A1-ATBiokit, S.A.K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.K011663MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLSThe 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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