FDA 510(k)

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

Numéro K : K172868 · 2018-02-28

Date de décision2018-02-28

Code produitDCN

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls 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 2018-02-28 under 510(k) number K172868. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K172868.

When did Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls receive FDA 510(k) clearance?

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172868.

Who is the listed applicant for Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

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 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls?

The FDA product code for Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls is DCN.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant The Binding Site Group , Ltd. en tant que demandeur

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit K192116Human IgA liquid reagent kit for Use on SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM Kit for use on SPAPlus

Voir tous les 17 dispositifs →

Dispositifs connexes (Code : DCN)

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.