FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIM MEDIUM
K Number: K792420
·
Decision Dec 31, 1979
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
52
Applicant Total
93
Review Days
34
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Basic Information
- Device Name
- SIM MEDIUM
- K Number
- K792420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Isle Media and Sterile Products, Inc.
- Date Received
- November 27, 1979
- Decision Date
- December 31, 1979
- Product Code
- JSE
- 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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSE), ordered by most recent decision date.
MLX MICROTITER PLATE LUMINOMETER
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FDA Class 1
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X-ACT UREA/TDA
FDA 510(k)
FDA Class 1
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X-ACT LDC/IND
FDA 510(k)
FDA Class 1
·Microbiology
MIL MEDIUM
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MRVP BROTH
FDA 510(k)
FDA Class 1
·Microbiology
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Isle Media and Sterile Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831671 | MODIFIED SOYBEAN CASEIN DIGEST BROTH | Jul 28, 1983 | Substantially Equivalent |
| K821218 | CAMPY-S AGAR | May 14, 1982 | Substantially Equivalent |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | Apr 16, 1982 | Substantially Equivalent |
| K812798 | MOTILITY GI MEDIUM | Oct 20, 1981 | Substantially Equivalent |
| K812796 | ANAEROBIC CNA BLOOD AGAR | Oct 20, 1981 | Substantially Equivalent |
| K812795 | ANAEROBIC BLOOD AGAR | Oct 20, 1981 | Substantially Equivalent |
| K812797 | SCHAEDLER AGARS | Oct 20, 1981 | Substantially Equivalent |
| K800818 | CHLAMYDOSPORE AGAR | Apr 24, 1980 | Substantially Equivalent |
| K800807 | CORN MEAL AGAR MEDIA | Apr 24, 1980 | Substantially Equivalent |
| K800334 | MARTIN-LEWIS AGAR | Mar 3, 1980 | Substantially Equivalent |