FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SS AGAR (MODIFIED)
K Number: K810931
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
284
Applicant Total
93
Review Days
8
Basic Information
- Device Name
- SS AGAR (MODIFIED)
- K Number
- K810931
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- OXOID U.S.A., INC.
- Date Received
- April 6, 1981
- Decision Date
- April 14, 1981
- Product Code
- JSI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Nov 4, 1986 | Substantially Equivalent |