FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYCHACO INDIRECT IMMUNOFLUORESCENCE
K Number: K830869
·
Decision Aug 11, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
17
Applicant Total
3
Review Days
146
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Basic Information
- Device Name
- POLYCHACO INDIRECT IMMUNOFLUORESCENCE
- K Number
- K830869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Parasitic Disease Consultants
- Date Received
- March 18, 1983
- Decision Date
- August 11, 1983
- 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 |
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