FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VISUWELL REAGIN TEST 960 TEST KIT
K Number: K885298
·
Decision Mar 15, 1989
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
2
Review Days
78
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Basic Information
- Device Name
- VISUWELL REAGIN TEST 960 TEST KIT
- K Number
- K885298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Allelix Diagnostics, Inc.
- Date Received
- December 27, 1988
- Decision Date
- March 15, 1989
- Product Code
- GMP
- 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 |
|---|---|---|---|
| GMP | Antisera, Control For Nontreponemal Tests | FDA class 2 | Microbiology |
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Other Clearances by Allelix Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880665 | MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT | Mar 1, 1988 | Substantially Equivalent |