FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRYPTIC SOY AGAR W/10% SHEEP BLOOD
K Number: K821417
·
Decision Jun 1, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- TRYPTIC SOY AGAR W/10% SHEEP BLOOD
- K Number
- K821417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Interstate Media
- Date Received
- May 12, 1982
- Decision Date
- June 1, 1982
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Interstate Media
| K Number | Device Name | ||
|---|---|---|---|
| K821422 | SS AGAR | Jun 1, 1982 | Substantially Equivalent |
| K821418 | TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD | Jun 1, 1982 | Substantially Equivalent |
| K821425 | COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD | Jun 1, 1982 | Substantially Equivalent |
| K821430 | MUELLER HINTON MEDIUM | Jun 1, 1982 | Substantially Equivalent |
| K821419 | EMB AGAR | Jun 1, 1982 | Substantially Equivalent |
| K821428 | MUELLER HINTON CHOCOLATE MED. ENRICHED | Jun 1, 1982 | Substantially Equivalent |
| K821426 | STAPHYLOCOCCUS MEDIUM 1100 | Jun 1, 1982 | Substantially Equivalent |
| K821420 | EMB AGAR | Jun 1, 1982 | Substantially Equivalent |
| K821429 | MUELLER HINTON MED. W/5% SHEEP BLOOD | Jun 1, 1982 | Substantially Equivalent |
| K821427 | MANNITOL SALT AGAR | Jun 1, 1982 | Substantially Equivalent |