FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARTIN-LEWIS AGAR
K Number: K841750
·
Decision May 31, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
11
Review Days
34
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Basic Information
- Device Name
- MARTIN-LEWIS AGAR
- K Number
- K841750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- The Montana Deaconess Medical Center
- Date Received
- April 27, 1984
- Decision Date
- May 31, 1984
- Product Code
- JTY
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | Microbiology |
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CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
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MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
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MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
FDA 510(k)
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·Microbiology
Other Clearances by The Montana Deaconess Medical Center
| K Number | Device Name | ||
|---|---|---|---|
| K841753 | MACCONKEY AGAR | Jun 7, 1984 | Substantially Equivalent |
| K841752 | XYLOSE-LYSINE DESOXYCHOLATE AGAR | Jun 7, 1984 | Substantially Equivalent |
| K841747 | MANNITOL SALT AGAR | Jun 7, 1984 | Substantially Equivalent |
| K841749 | CHOCOLATE AGAR | May 31, 1984 | Substantially Equivalent |
| K841748 | SHEEP BLOOD AGAR | May 31, 1984 | Substantially Equivalent |
| K841751 | LEVINE EOSIN METHYLENE BLUE AGAR | May 31, 1984 | Substantially Equivalent |
| K841746 | SALMONELLA-SHIGELLA AGAR | May 31, 1984 | Substantially Equivalent |
| K841755 | MUELLER-HINTON AGAR | May 14, 1984 | Substantially Equivalent |
| K841745 | HEKTOEN ENTERIC AGAR | May 11, 1984 | Substantially Equivalent |
| K841754 | COLUMBIA CNA AGAR | May 7, 1984 | Substantially Equivalent |