FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FISHER DIAGNOSTIC LATEST ASO TEST KIT
K Number: K852701
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
1
Review Days
23
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Basic Information
- Device Name
- FISHER DIAGNOSTIC LATEST ASO TEST KIT
- K Number
- K852701
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Allied Fisher Scientific
- Date Received
- June 26, 1985
- Decision Date
- July 19, 1985
- Product Code
- GTQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | FDA class 1 | Microbiology |
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VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
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