FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VISUWELL(R) REAGIN TEST (MODIFICATION)
K Number: K900338
·
Decision Apr 10, 1990
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
4
Review Days
77
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Basic Information
- Device Name
- VISUWELL(R) REAGIN TEST (MODIFICATION)
- K Number
- K900338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Adi Diagnostics, Inc.
- Date Received
- January 23, 1990
- Decision Date
- April 10, 1990
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
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