London Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | December 17, 1991 |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | August 2, 1991 |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | July 30, 1991 |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | February 4, 1991 |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | October 12, 1990 |
| K903130 | LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY | September 25, 1990 |
| K902443 | LUMATAG(TM) LH DIAGNOSTIC KIT | August 2, 1990 |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | August 2, 1990 |
| K901484 | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC | May 1, 1990 |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | April 2, 1990 |
| K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY | May 27, 1988 |
| K880296 | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY | March 24, 1988 |