FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIPLE SUGAR IRON AGAR (TSI AGAR)
K Number: K791473
·
Decision Aug 22, 1979
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
52
Applicant Total
93
Review Days
26
Basic Information
- Device Name
- TRIPLE SUGAR IRON AGAR (TSI AGAR)
- K Number
- K791473
- 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
- July 27, 1979
- Decision Date
- August 22, 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 |
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Other Clearances by ISLE MEDIA AND STERILE PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K821218 | CAMPY-S AGAR | May 14, 1982 | Substantially Equivalent |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | Apr 16, 1982 | Substantially Equivalent |
| K812796 | ANAEROBIC CNA BLOOD AGAR | Oct 20, 1981 | Substantially Equivalent |
| K812795 | ANAEROBIC BLOOD AGAR | Oct 20, 1981 | Substantially Equivalent |
| K812798 | MOTILITY GI MEDIUM | 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 |
| K800333 | MODIFIED THAYER-MARTIN X AGAR | Mar 3, 1980 | Substantially Equivalent |