U. S. Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 22
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | September 21, 2011 |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | February 20, 2009 |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | January 12, 2007 |
| K051651 | G4, MODEL IGM-0004 | April 14, 2006 |
| K870687 | COAGULATION CONTROL, LEVEL III | April 20, 1987 |
| K870686 | COAGULATION CONTROL, LEVEL II | April 20, 1987 |
| K870596 | PROTHROMBIN TIME TEST | April 20, 1987 |
| K870685 | COAGULATION CONTROL, LEVEL I | April 20, 1987 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | April 15, 1987 |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | April 13, 1987 |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | April 13, 1987 |
| K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II | April 6, 1987 |
| K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I | April 6, 1987 |
| K870688 | O.O2 M CALCIUM CHLORIDE SOLUTION | March 31, 1987 |
| K864231 | U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST | December 4, 1986 |
| K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST | December 4, 1986 |
| K863980 | U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST | December 4, 1986 |
| K863889 | UREA NITROGEN TEST | November 24, 1986 |
| K864119 | URIC ACID TEST | October 29, 1986 |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | October 3, 1986 |