FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT


codes

Device Classification Name

radioimmunoassay, acth

510(k) Number K002638
Device Name FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
Original Applicant
FUTURE DIAGNOSTICS B.V.
4079 mt. barnard
san diego, 
CA 
92111

Original Contact dave d smith
Regulation Number 862.1025
Classification Product Code
CKG  
Date Received 08/24/2000
Decision Date 01/17/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No