FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAPHYLOCOCCUS MEDIUM 1100
K Number: K821426
·
Decision Jun 1, 1982
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- STAPHYLOCOCCUS MEDIUM 1100
- K Number
- K821426
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Interstate Media
- Date Received
- May 12, 1982
- Decision Date
- June 1, 1982
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, 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 |
| K821417 | TRYPTIC SOY AGAR W/10% SHEEP BLOOD | 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 |
| 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 |