FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
K Number: K853484
·
Decision Feb 5, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
2
Review Days
169
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Basic Information
- Device Name
- INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
- K Number
- K853484
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biotech Research Laboratories, Inc.
- Date Received
- August 20, 1985
- Decision Date
- February 5, 1986
- Product Code
- GNP
- 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | FDA class 1 | Microbiology |
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Other Clearances by Biotech Research Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Aug 12, 1982 | Substantially Equivalent |