FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MALT AGAR
K Number: K844932
·
Decision Feb 27, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
36
Review Days
70
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Basic Information
- Device Name
- MALT AGAR
- K Number
- K844932
- 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
- December 19, 1984
- Decision Date
- February 27, 1985
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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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 |
| 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 |
| K820559 | ANAEROBE BLOOD AGAR | Mar 19, 1982 | Substantially Equivalent |