MODIFICATION TO PARA 5X


Device Classification Name

mixture, hematology quality control

510(k) Number K021922
Device Name MODIFICATION TO PARA 5X
Original Applicant
STRECK LABORATORIES, INC.
7002 south 109th st.
la vista, 
NE 
68128

Original Contact paul kittelson
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 06/11/2002
Decision Date 06/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized