Company ยท GB
Mercia Diagnostics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1992. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 4 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| JWZ | Kit, Screening, Trichomonas | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 |
| GOB | Antigens, Ha (Including Ha Control), Adenovirus 1-33 | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 |
| LRF | Candida Spp., Direct Antigen, Id | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 1992 | K915479 | CAPTIA CMV-TA Mercia Diagnostics , Ltd., GB | LFZ |
| Dec 26, 1990 | K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION Mercia Diagnostics , Ltd., GB | LIP |
| Mar 8, 1990 | K900654 | MODIFIED CAPTIA(R) SYPHILIS-M Mercia Diagnostics , Ltd., GB | LIP |
| Mar 6, 1990 | K900655 | MODIFIED CAPTIA(R) TOXO-M Mercia Diagnostics , Ltd., GB | LGD |
| Mar 6, 1990 | K896295 | CAPTIA(R) CMV-M Mercia Diagnostics , Ltd., GB | LFZ |
| Mar 6, 1990 | K896194 | CAPTIA(R) CMV-G Mercia Diagnostics , Ltd., GB | LFZ |
| Aug 15, 1989 | K885300 | CAPTIA(R) RUBELLA-M Mercia Diagnostics , Ltd., GB | LFX |
| Aug 15, 1989 | K883924 | CAPTIA(R) RUBELLA-G Mercia Diagnostics , Ltd., GB | LFX |
| Jun 13, 1989 | K892802 | SUPER DUO Mercia Diagnostics , Ltd., GB | JWZ |
| Aug 4, 1988 | K881425 | CAPTIA(R) SYPHILIS-G Mercia Diagnostics , Ltd., GB | LIP |
| Aug 1, 1988 | K880918 | CAPTIA TOXO-G Mercia Diagnostics , Ltd., GB | LGD |
| May 13, 1988 | K875138 | TRICHOMATE(R) SUPER Mercia Diagnostics , Ltd., GB | JWZ |
| Nov 27, 1987 | K873740 | ROTASCREEN EIA Mercia Diagnostics , Ltd., GB | LIQ |
| Sep 14, 1987 | K872568 | ROTASCREEN Mercia Diagnostics , Ltd., GB | GOB |
| Aug 7, 1987 | K871548 | CAPTIA(R) SYPHILIS-M Mercia Diagnostics , Ltd., GB | LIP |
| Jul 31, 1987 | K871746 | CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY Mercia Diagnostics , Ltd., GB | LGD |
| Mar 19, 1987 | K863499 | CANDIDATE(R) SUPER Mercia Diagnostics , Ltd., GB | LRF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||