FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXOPLASMOSIS TEST KIT
K Number: K811562
·
Decision Jul 16, 1981
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
17
Applicant Total
8
Review Days
43
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Basic Information
- Device Name
- TOXOPLASMOSIS TEST KIT
- K Number
- K811562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Diagnostic Products, Inc.
- Date Received
- June 3, 1981
- Decision Date
- July 16, 1981
- Product Code
- GLZ
- 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 |
|---|---|---|---|
| GLZ | Antigens, If, Toxoplasma Gondii | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GLZ), ordered by most recent decision date.
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ANTI-TOXOPLASMA GONDII KIT
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IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Immuno-Diagnostic Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Apr 24, 1986 | Substantially Equivalent |
| K811021 | HERPES | Nov 5, 1981 | Substantially Equivalent |
| K811022 | ANA TEST KIT | Apr 23, 1981 | Substantially Equivalent |
| K801959 | FTA-ABS TEST | Oct 23, 1980 | Substantially Equivalent |
| K801963 | CMV TEST KIT | Oct 23, 1980 | Substantially Equivalent |
| K801960 | ANTI-DS/N-DNA TEST KIT | Oct 10, 1980 | Substantially Equivalent |
| K801961 | RF-II TEST KIT | Oct 10, 1980 | Substantially Equivalent |