FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTI-EPSTEIN-BARR VIRUS KIT
K Number: K842662
·
Decision Dec 12, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
32
Review Days
520
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Basic Information
- Device Name
- ANTI-EPSTEIN-BARR VIRUS KIT
- K Number
- K842662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Amico Lab, Inc.
- Date Received
- July 10, 1984
- Decision Date
- December 12, 1985
- Product Code
- GNP
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | FDA class 1 | Microbiology |
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Other Clearances by Amico Lab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842530 | AMIZYME-EBV TEST KIT | Dec 6, 1985 | Substantially Equivalent |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Dec 6, 1985 | Substantially Equivalent |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Dec 6, 1985 | Substantially Equivalent |
| K842529 | AMIZYME-CMV KIT | Dec 6, 1985 | Substantially Equivalent |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Dec 6, 1985 | Substantially Equivalent |
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | Oct 30, 1984 | Substantially Equivalent |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | Oct 1, 1984 | Substantially Equivalent |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | Oct 1, 1984 | Substantially Equivalent |
| K842532 | AMIZYME-ANA TEST KIT | Sep 20, 1984 | Substantially Equivalent |
| K842533 | AMIZYME-ANDNA TEST KIT | Sep 20, 1984 | Substantially Equivalent |