FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K Number: K851202
·
Decision Apr 29, 1985
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
27
Applicant Total
10
Review Days
34
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Basic Information
- Device Name
- GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
- K Number
- K851202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Gilford
- Date Received
- March 26, 1985
- Decision Date
- April 29, 1985
- Product Code
- DAK
- 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 |
|---|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Gilford
| K Number | Device Name | ||
|---|---|---|---|
| K853465 | GILFORD IMMUNOGLOBULIN G REAGENT | Sep 16, 1985 | Substantially Equivalent |
| K853467 | GILFORD IMMUNOGLOBULIN A REAGENT | Sep 16, 1985 | Substantially Equivalent |
| K853468 | GILFORD C4 COMPLEMENT REAGENT | Sep 16, 1985 | Substantially Equivalent |
| K853469 | GILFORD IMMUNOGLOBULIN M REAGENT | Sep 16, 1985 | Substantially Equivalent |
| K853466 | GILFORD C3 COMPLEMENT REAGENT | Sep 16, 1985 | Substantially Equivalent |
| K842500 | DATA MGMT. SYSTEM | Aug 16, 1984 | Substantially Equivalent |
| K840120 | ADVANTAGE | Mar 23, 1984 | Substantially Equivalent |
| K833067 | IMPACT 400 #1447X2 | Dec 8, 1983 | Substantially Equivalent |
| K812787 | EIA RUBELLA | Nov 27, 1981 | Substantially Equivalent |