SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS


Device Classification Name

ferrozine (colorimetric) iron binding capacity

510(k) Number K960485
Device Name SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd.
w-337
brea, 
CA 
92821 -6208

Applicant Contact sheri hall
Correspondent
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd.
w-337
brea, 
CA 
92821 -6208

Correspodent Contact sheri hall
Regulation Number 862.1415
Classification Product Code
JMO  
Subsequent Product Code
JIT  
Date Received 02/02/1996
Decision Date 05/10/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized