Mercia Diagnostics , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K915479 | CAPTIA CMV-TA | May 4, 1992 |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | December 26, 1990 |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | March 8, 1990 |
| K896194 | CAPTIA(R) CMV-G | March 6, 1990 |
| K896295 | CAPTIA(R) CMV-M | March 6, 1990 |
| K900655 | MODIFIED CAPTIA(R) TOXO-M | March 6, 1990 |
| K885300 | CAPTIA(R) RUBELLA-M | August 15, 1989 |
| K883924 | CAPTIA(R) RUBELLA-G | August 15, 1989 |
| K892802 | SUPER DUO | June 13, 1989 |
| K881425 | CAPTIA(R) SYPHILIS-G | August 4, 1988 |
| K880918 | CAPTIA TOXO-G | August 1, 1988 |
| K875138 | TRICHOMATE(R) SUPER | May 13, 1988 |
| K873740 | ROTASCREEN EIA | November 27, 1987 |
| K872568 | ROTASCREEN | September 14, 1987 |
| K871548 | CAPTIA(R) SYPHILIS-M | August 7, 1987 |
| K871746 | CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY | July 31, 1987 |
| K863499 | CANDIDATE(R) SUPER | March 19, 1987 |