Company ยท US
Wellcome Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1992. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GTJ | Antisera, All Groups, N. Meningitidis | 5 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| GNB | Antisera, All Types, Shigella Spp. | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| GRD | Antiserum, Hai, Mumps Virus | 1 |
| GRM | Antisera, All Groups, Salmonella Spp. | 1 |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 1 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
| JCO | Bothrops Atrox Reagent | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
| KFF | Assay, Heparin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 1992 | K915203 | D-DIMER WELLCOTEST (HA10) Wellcome Diagnostics | DAP |
| Mar 29, 1991 | K910797 | STREPTEX ACID EXTRACTION KIT Wellcome Diagnostics | GTZ |
| Jan 11, 1990 | K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 Wellcome Diagnostics | GNB |
| Feb 16, 1989 | K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 Wellcome Diagnostics | GRM |
| Aug 3, 1988 | K875311 | WELLCOZYME HSV WZO2 Wellcome Diagnostics | GQN |
| Jan 21, 1987 | K861628 | WELLCOZYME ROTAVIRUS WZ01 Wellcome Diagnostics | LIQ |
| Jan 13, 1987 | K864206 | REVEAL COLOUR STREP A ZL16 Wellcome Diagnostics | GTZ |
| Oct 29, 1986 | K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 Wellcome Diagnostics | LIQ |
| Feb 4, 1986 | K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT Wellcome Diagnostics | GTJ |
| Feb 4, 1986 | K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 Wellcome Diagnostics | GTJ |
| Jun 10, 1985 | K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 Wellcome Diagnostics | GTJ |
| Jun 4, 1985 | K844762 | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 Wellcome Diagnostics | GTJ |
| May 22, 1985 | K851949 | STAPHAUREX ZL30 Wellcome Diagnostics | GTN |
| Aug 16, 1984 | K842827 | STREPTEX DIRECT A ZL14 Wellcome Diagnostics | GTZ |
| Aug 15, 1984 | K842828 | STREPTEX ZL01 Wellcome Diagnostics | JTO |
| May 2, 1984 | K841376 | WELLCOGEN S. PNEUMONIAE Wellcome Diagnostics | GWC |
| Apr 23, 1984 | K840210 | REPTILASE-R HA35 Wellcome Diagnostics | JCO |
| Mar 2, 1984 | K840211 | FIBRI-PREST AUTOMATE HA34 Wellcome Diagnostics | KQJ |
| Jan 10, 1984 | K833077 | WELLCOGEN H. INFLUENZAL ZL21 Wellcome Diagnostics | GRD |
| Jan 10, 1984 | K833063 | WELLCOGEN N. MENINGITIDIS A,C,Y W135 Wellcome Diagnostics | GTJ |
| Nov 21, 1983 | K832591 | DIACROM *PLG Wellcome Diagnostics | DDX |
| Sep 29, 1983 | K832592 | DIACROM * ATIII Wellcome Diagnostics | JBQ |
| Sep 29, 1983 | K832373 | DIACROM * HEPARIN Wellcome Diagnostics | KFF |
| Sep 29, 1983 | K832372 | DIACROM * FACTOR X KIT HA31 Wellcome Diagnostics | GGP |
| Sep 1, 1983 | K831073 | DAC-CEL HCG-MCA KIT RD52 Wellcome Diagnostics | CFL |
| Jun 16, 1983 | K831069 | DAC-CEL PTH KIT RD51 Wellcome Diagnostics | CEW |
| Feb 18, 1983 | K830204 | DAC-CEL DIAGNATAL HCG STANDARDS RD49 Wellcome Diagnostics | JJX |
| Feb 18, 1983 | K830203 | DAC-CEL DIAGNATAL RD 50 Wellcome Diagnostics | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||