International Enzymes, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011169HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3May 18, 2001
K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, IIIAugust 20, 1996
K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMSeptember 15, 1995
K953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMSeptember 15, 1995
K950802LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEMJune 1, 1995
K944513LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-EDecember 2, 1994
K944486LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - EDecember 2, 1994