FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
K Number: K832258
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
14
Review Days
123
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Basic Information
- Device Name
- GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
- K Number
- K832258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Gelco Diagnostics, Inc.
- Date Received
- June 30, 1983
- Decision Date
- October 31, 1983
- Product Code
- DEW
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
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IGG
FDA 510(k)
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Other Clearances by Gelco Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832267 | FITC GOAT ANTI-HUMAN LAMBA | Oct 31, 1983 | Substantially Equivalent |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Oct 31, 1983 | Substantially Equivalent |
| K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN | Oct 31, 1983 | Substantially Equivalent |
| K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- | Oct 31, 1983 | Substantially Equivalent |
| K832270 | GOAT ANTI-HUMAN LAMBA | Oct 31, 1983 | Substantially Equivalent |
| K832260 | GOAT ANTI-HUMAN KAPPA AFFINITY | Oct 31, 1983 | Substantially Equivalent |
| K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY | Oct 31, 1983 | Substantially Equivalent |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | Oct 31, 1983 | Substantially Equivalent |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Oct 28, 1983 | Substantially Equivalent |
| K832259 | GOAT ANTI-HUMAN IGM H CHAIN | Oct 28, 1983 | Substantially Equivalent |