Streck Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
70
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042587RETIC-CHEX FOR CELL-DYNOctober 19, 2004
K040107CYTO-CHEX BCTJuly 27, 2004
K040025A1C-CELLULARMarch 2, 2004
K023656SICKLE-CHEX SOLUBILITY KITDecember 30, 2002
K021922MODIFICATION TO PARA 5XJune 25, 2002
K020469CAL-CHEX CD PLUSApril 4, 2002
K013316SICKLE-CHEXNovember 6, 2001
K011410PARA 5XJune 26, 2001
K001443SUGAR CHEX ONEJune 29, 2000
K000945PARA 12 PLUS RETICSApril 18, 2000
K000115RETIC CHEX LINEARITYMarch 27, 2000
K000076CELL-CHEXMarch 3, 2000
K994388XE CHECKJanuary 14, 2000
K993825PARA TECH PLUS RETICSNovember 30, 1999
K993126CD-CHEX CD 34November 26, 1999
K992887STAK-CHEX PLUS RETICSNovember 22, 1999
K982290CHEM-CHEX STAT (NEW)July 22, 1998
K960894CD-CHEX + RBCMay 24, 1996
K961195CHEM-CHEX STATMay 15, 1996
K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)April 3, 1996