Burroughs Wellcome Co.
Medical device manufacturer in Mchenry, IL.
17510(k) clearances
0PMA approvals
0recalls
Device types
- DON Radioimmunoassay, Digoxin (125-I), Rabbit… 2
- DDC Thyroglobulin, Antigen, Antiserum, Control 2
- GTZ Antisera, All Groups, Streptococcus Spp. 2
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- DCN System, Test, C-Reactive Protein 1
- GTJ Antisera, All Groups, N. Meningitidis 1
- DAC Complement C3b Activator, Antigen… 1
- GMM Antigens, Iha, Toxoplasma Gondii 1
- CDX Radioimmunoassay, Total Thyroxine 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- KTS Second Antibody (Species Specific… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K820069 | Wellcogen Group BGTZ · Traditional | 02/18/1982SE |
| K813508 | Sac-CelKTS · Traditional | 12/29/1981SE |
| K810215 | Dac-Cel HCGJHI · Traditional | 04/17/1981SE |
| K810214 | Dac-Cel DiagnatalJHI · Traditional | 03/06/1981SE |
| K810213 | Dac-Cel TSHJLW · Traditional | 02/10/1981SE |
| K810212 | Dac-Cel T3 UptakeKHQ · Traditional | 02/10/1981SE |
| K791232 | Dac-Cel T3CDP · Traditional | 09/04/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | 09/04/1979SE |
| K781607 | Strep-TexGTZ · Traditional | 10/17/1978SE |
| K780874 | Thymune-TDDC · Traditional | 06/14/1978SE |
| K780873 | Thymune-MDDC · Traditional | 06/14/1978SE |
| K780475 | Dac-Cel Digoxin Radioimmunoassay KitDON · Traditional | 04/24/1978SE |
| K771560 | Toxha TestGMM · Traditional | 09/15/1977SE |
| K771583 | Fluorescent Anti. Anti-Human C3DAC · Traditional | 09/02/1977SE |
| K771562 | Agglutinating Serum W135GTJ · Traditional | 08/25/1977SE |
| K771139 | Crp-WellcotestDCN · Traditional | 07/14/1977SE |
| K770269 | Cammadisk DigoxinDON · Traditional | 03/16/1977SE |