FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EIA RUBELLA
K Number: K812787
·
Decision Nov 27, 1981
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
10
Review Days
53
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Basic Information
- Device Name
- EIA RUBELLA
- K Number
- K812787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gilford
- Date Received
- October 5, 1981
- Decision Date
- November 27, 1981
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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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 |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Apr 29, 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 |