FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIX RAPID CHOLERA STRIP TEST
K Number: K954995
·
Decision Aug 15, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
2
Applicant Total
4
Review Days
289
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Basic Information
- Device Name
- QUIX RAPID CHOLERA STRIP TEST
- K Number
- K954995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3930
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Guardian Scientific, Corp.
- Date Received
- October 31, 1995
- Decision Date
- August 15, 1996
- Product Code
- GSQ
- 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 |
|---|---|---|---|
| GSQ | Antiserum, Vibrio Cholerae, All Varieties | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GSQ), ordered by most recent decision date.
CHOLERA SMART(TM)
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