International Enzymes, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 | May 18, 2001 |
| K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | August 20, 1996 |
| K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | September 15, 1995 |
| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | September 15, 1995 |
| K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM | June 1, 1995 |
| K944513 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E | December 2, 1994 |
| K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E | December 2, 1994 |