FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELENITE BROTH
K Number: K820558
·
Decision Mar 16, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
25
Applicant Total
36
Review Days
14
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Basic Information
- Device Name
- SELENITE BROTH
- K Number
- K820558
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Laboratory Supply, Inc.
- Date Received
- March 2, 1982
- Decision Date
- March 16, 1982
- Product Code
- JSD
- 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 |
|---|---|---|---|
| JSD | Culture Media, Selective Broth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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TODD HEWITT W/CNA (LIM BROTH)
FDA 510(k)
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Other Clearances by American Laboratory Supply, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852578 | CLED AGAR | Jul 12, 1985 | Substantially Equivalent |
| K844929 | INHIBITORY MOLD AGAR | Feb 27, 1985 | Substantially Equivalent |
| K844930 | BRILLANT GREEN AGAR | Feb 27, 1985 | Substantially Equivalent |
| K844931 | MYCOLOGICAL AGAR W/ANTIBIOTICS | Feb 27, 1985 | Substantially Equivalent |
| K844932 | MALT AGAR | Feb 27, 1985 | Substantially Equivalent |
| K844933 | BILE ESCULIN AGAR | Feb 27, 1985 | Substantially Equivalent |
| K844934 | AZIDE AGAR W/5% SHEEP BLOOD | Feb 25, 1985 | Substantially Equivalent |
| K820561 | SABOURAUD DEXTROSE AGAR | Mar 19, 1982 | Substantially Equivalent |
| K820557 | DERMATHPHYTE TEST MEDIUM | Mar 19, 1982 | Substantially Equivalent |
| K820560 | PHENYLETHANOL AGAR W/5% SHEEP BLOOD | Mar 19, 1982 | Substantially Equivalent |