TAS HMT CONTROLS


Device Classification Name

plasma, coagulation control

510(k) Number K960234
Device Name TAS HMT CONTROLS
Applicant
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 departure dr.
raleigh, 
NC 
27616

Applicant Contact cynthia pritchard
Correspondent
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 departure dr.
raleigh, 
NC 
27616

Correspodent Contact cynthia pritchard
Regulation Number 864.5425
Classification Product Code
GGN  
Subsequent Product Codes
GGC   GIZ   JJX  
Date Received 01/17/1996
Decision Date 05/30/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No