FDA 510(k), K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
FDA 510(k), K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
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510(K) Number: K080092
Device Name: ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Manufacturer:
Device Classification Name: System, Test, Thyroid Autoantibody
Regulation Number: 866.5870
Classification Product Code: JZO
Date Received: 01/14/2008
Decision Date: 07/28/2008
Regulation Medical Specialty: Immunology
Device Name: ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Manufacturer:
Device Classification Name: System, Test, Thyroid Autoantibody
Regulation Number: 866.5870
Classification Product Code: JZO
Date Received: 01/14/2008
Decision Date: 07/28/2008
Regulation Medical Specialty: Immunology