FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEVINE EOSIN METHYLER
K Number: K791555
·
Decision Sep 17, 1979
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
36
Review Days
31
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Basic Information
- Device Name
- LEVINE EOSIN METHYLER
- K Number
- K791555
- 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
- August 17, 1979
- Decision Date
- September 17, 1979
- 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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|---|---|---|---|
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| 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 |