Clinical Controls, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012907LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROLSeptember 28, 2001
K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,ANDNovember 22, 1996
K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROLJuly 5, 1996
K955691SERUM VOLATILES CONTROL LEVEL 1 & 2April 24, 1996
K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3April 24, 1996
K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3August 24, 1995
K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2May 2, 1995
K946049LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2February 10, 1995
K946048LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2February 10, 1995
K946050LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2February 10, 1995
K946266FERRITIN CONTROL - LEVEL 1, 2, 3February 10, 1995
K946144LIQUISPEX(TM) URINE ETHANOL CONTROLFebruary 8, 1995
K946143CHEMSPEX(TM) AMMONIA CONTROLFebruary 3, 1995
K946145CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROLJanuary 24, 1995
K946146CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITIONJanuary 24, 1995
K944923CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,November 4, 1994
K935599HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3October 31, 1994
K934741LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2September 8, 1994