FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K Number: K822681
·
Decision Dec 13, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
32
Review Days
101
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Basic Information
- Device Name
- ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
- K Number
- K822681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Amico Lab, Inc.
- Date Received
- September 3, 1982
- Decision Date
- December 13, 1982
- Product Code
- DHN
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Amico Lab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Dec 12, 1985 | Substantially Equivalent |
| 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 |