Trace Scientific , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 55
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | September 17, 1998 |
| K981123 | UREA | April 24, 1998 |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | September 27, 1996 |
| K961114 | AST INCORPORATING DST | May 23, 1996 |
| K961123 | ALT INCORPORATING DST | April 25, 1996 |
| K952488 | TRACE COBAS MIRA RANGE | October 13, 1995 |
| K932713 | TRACE TRANSFERRIN REAGENT | September 30, 1993 |
| K923322 | TRACE ALBUMIN-MR REAGENT | September 11, 1992 |
| K914731 | TRACE GAMMA GT-SS REAGENT | November 19, 1991 |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | July 17, 1991 |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | October 1, 1990 |
| K904116 | IRON 5 X CONC REAGENT | September 27, 1990 |
| K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT | September 25, 1990 |
| K903896 | CALCIUM ARSENAZO III REAGENT | September 13, 1990 |
| K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | May 22, 1989 |
| K891470 | CK-NAC 2-VIAL REAGENT W/SUBSTRATE START | May 9, 1989 |
| K890996 | LD1 ISOENZYME REAGENT KIT | May 5, 1989 |
| K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | April 4, 1989 |
| K890070 | TOTAL BILIRUBIN REAGENT, CONCENTRATED | March 6, 1989 |
| K881938 | BICARBONATE (CO2) REAGENT-2 VIAL | June 15, 1988 |