FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTAZYME TOXOPLASMA
K Number: K790360
·
Decision May 22, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
17
Applicant Total
318
Review Days
89
Basic Information
- Device Name
- QUANTAZYME TOXOPLASMA
- K Number
- K790360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- BIO-RAD
- Date Received
- February 22, 1979
- Decision Date
- May 22, 1979
- 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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IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
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