FDA 510(k), K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

$89.00 USD

Sale Sold out

510(K) Number: K080092
Device Name: ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Manufacturer: ROCHE DIAGNOSTICS CORP.
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