FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
K Number: K890840
·
Decision Mar 27, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
4
Review Days
34
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Basic Information
- Device Name
- VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
- K Number
- K890840
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Adi Diagnostics, Inc.
- Date Received
- February 21, 1989
- Decision Date
- March 27, 1989
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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