SICKLE-CHEX SOLUBILITY KIT


Device Classification Name

test, sickle cell

510(k) Number K023656
Device Name SICKLE-CHEX SOLUBILITY KIT
Original Applicant
STRECK LABORATORIES, INC.
7002 south 109th st.
la vista, 
NE 
68128

Original Contact carol thompson
Regulation Number 864.7825
Classification Product Code
GHM  
Date Received 10/30/2002
Decision Date 12/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No