FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT


the company

Device Classification Name

radioimmunoassay, parathyroid hormone

510(k) Number K000471
Device Name FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
Original Applicant
FUTURE DIAGNOSTICS B.V.
4079 mt. barnard
san diego, 
CA 
92111

Original Contact dave d smith
Regulation Number 862.1545
Classification Product Code
CEW  
Date Received 02/14/2000
Decision Date 04/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No