FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WELLCOGEN GROUP B
K Number: K820069
·
Decision Feb 18, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
17
Review Days
37
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Basic Information
- Device Name
- WELLCOGEN GROUP B
- K Number
- K820069
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Burroughs Wellcome Co.
- Date Received
- January 12, 1982
- Decision Date
- February 18, 1982
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by Burroughs Wellcome Co.
| K Number | Device Name | ||
|---|---|---|---|
| K813508 | SAC-CEL | Dec 29, 1981 | Substantially Equivalent |
| K810215 | DAC-CEL HCG | Apr 17, 1981 | Substantially Equivalent |
| K810214 | DAC-CEL DIAGNATAL | Mar 6, 1981 | Substantially Equivalent |
| K810213 | DAC-CEL TSH | Feb 10, 1981 | Substantially Equivalent |
| K810212 | DAC-CEL T3 UPTAKE | Feb 10, 1981 | Substantially Equivalent |
| K791231 | DAC-CEL T4 | Sep 4, 1979 | Substantially Equivalent |
| K791232 | DAC-CEL T3 | Sep 4, 1979 | Substantially Equivalent |
| K781607 | STREP-TEX | Oct 17, 1978 | Substantially Equivalent |
| K780873 | THYMUNE-M | Jun 14, 1978 | Substantially Equivalent |
| K780874 | THYMUNE-T | Jun 14, 1978 | Substantially Equivalent |