Burroughs Wellcome Co.
Mchenry, IL, US
Burroughs Wellcome Co. appears in FDA device records in Mchenry, IL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Burroughs Wellcome Co. between 1977 and 1982. The busiest year on record is 1977, with 5. The most recent is 1982, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 5 |
| 1978 | 4 |
| 1979 | 2 |
| 1981 | 5 |
| 1982 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K820069 | WELLCOGEN GROUP B | GTZ | Substantially Equivalent | |
| K813508 | SAC-CEL | KTS | Substantially Equivalent | |
| K810215 | DAC-CEL HCG | JHI | Substantially Equivalent | |
| K810214 | DAC-CEL DIAGNATAL | JHI | Substantially Equivalent | |
| K810213 | DAC-CEL TSH | JLW | Substantially Equivalent | |
| K810212 | DAC-CEL T3 UPTAKE | KHQ | Substantially Equivalent | |
| K791232 | DAC-CEL T3 | CDP | Substantially Equivalent | |
| K791231 | DAC-CEL T4 | CDX | Substantially Equivalent | |
| K781607 | STREP-TEX | GTZ | Substantially Equivalent | |
| K780874 | THYMUNE-T | DDC | Substantially Equivalent | |
| K780873 | THYMUNE-M | DDC | Substantially Equivalent | |
| K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT | DON | Substantially Equivalent | |
| K771560 | TOXHA TEST | GMM | Substantially Equivalent | |
| K771583 | FLUORESCENT ANTI. ANTI-HUMAN C3 | DAC | Substantially Equivalent | |
| K771562 | AGGLUTINATING SERUM W135 | GTJ | Substantially Equivalent | |
| K771139 | CRP-WELLCOTEST | DCN | Substantially Equivalent | |
| K770269 | CAMMADISK DIGOXIN | DON | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GMMAntigens, Iha, Toxoplasma Gondii
- GTJAntisera, All Groups, N. Meningitidis
- GTZAntisera, All Groups, Streptococcus Spp.
- DACComplement C3b Activator, Antigen, Antiserum, Control
- KHQRadioassay, Triiodothyronine Uptake
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)
- DCNSystem, Test, C-Reactive Protein
- DDCThyroglobulin, Antigen, Antiserum, Control
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain