Company ยท US
Burroughs Wellcome Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1982. 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 |
|---|---|---|
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 2 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| DAC | Complement C3b Activator, Antigen, Antiserum, Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KTS | Second Antibody (Species Specific Anti-Animal Gamma Globulin) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1982 | K820069 | WELLCOGEN GROUP B Burroughs Wellcome Co. | GTZ |
| Dec 29, 1981 | K813508 | SAC-CEL Burroughs Wellcome Co. | KTS |
| Apr 17, 1981 | K810215 | DAC-CEL HCG Burroughs Wellcome Co. | JHI |
| Mar 6, 1981 | K810214 | DAC-CEL DIAGNATAL Burroughs Wellcome Co. | JHI |
| Feb 10, 1981 | K810213 | DAC-CEL TSH Burroughs Wellcome Co. | JLW |
| Feb 10, 1981 | K810212 | DAC-CEL T3 UPTAKE Burroughs Wellcome Co. | KHQ |
| Sep 4, 1979 | K791232 | DAC-CEL T3 Burroughs Wellcome Co. | CDP |
| Sep 4, 1979 | K791231 | DAC-CEL T4 Burroughs Wellcome Co. | CDX |
| Oct 17, 1978 | K781607 | STREP-TEX Burroughs Wellcome Co. | GTZ |
| Jun 14, 1978 | K780874 | THYMUNE-T Burroughs Wellcome Co. | DDC |
| Jun 14, 1978 | K780873 | THYMUNE-M Burroughs Wellcome Co. | DDC |
| Apr 24, 1978 | K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT Burroughs Wellcome Co. | DON |
| Sep 15, 1977 | K771560 | TOXHA TEST Burroughs Wellcome Co. | GMM |
| Sep 2, 1977 | K771583 | FLUORESCENT ANTI. ANTI-HUMAN C3 Burroughs Wellcome Co. | DAC |
| Aug 25, 1977 | K771562 | AGGLUTINATING SERUM W135 Burroughs Wellcome Co. | GTJ |
| Jul 14, 1977 | K771139 | CRP-WELLCOTEST Burroughs Wellcome Co. | DCN |
| Mar 16, 1977 | K770269 | CAMMADISK DIGOXIN Burroughs Wellcome Co. | DON |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||