FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
K Number: K760148
·
Decision Jul 20, 1976
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
43
Applicant Total
9
Review Days
21
Basic Information
- Device Name
- SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
- K Number
- K760148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- OXFORD LABORATORIES, INC.
- Date Received
- June 29, 1976
- Decision Date
- July 20, 1976
- Product Code
- CZW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by OXFORD LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K780912 | ADJUSTABLE DISPENSOR | Jun 28, 1978 | Substantially Equivalent |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Jul 20, 1976 | Substantially Equivalent |
| K760078 | REAGENT, RIA TRIIODOTHYRONINE T3 (#200) | Jul 20, 1976 | Substantially Equivalent |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760079 | REAGENT, THYROXINE T4 (#210) | Jul 20, 1976 | Substantially Equivalent |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | Jul 19, 1976 | Substantially Equivalent |