FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTI-SCHISTOSOMA SPECIES KIT
K Number: K842660
·
Decision Oct 30, 1984
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
1
Applicant Total
32
Review Days
112
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Basic Information
- Device Name
- ANTI-SCHISTOSOMA SPECIES KIT
- K Number
- K842660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3600
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Amico Lab, Inc.
- Date Received
- July 10, 1984
- Decision Date
- October 30, 1984
- Product Code
- GNH
- 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 |
|---|---|---|---|
| GNH | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNH), ordered by most recent decision date.
View allOther 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 |
| 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 |