FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI
K Number: K850732
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI
- K Number
- K850732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Roseville Medical Laboratoriesu
- Date Received
- February 20, 1985
- Decision Date
- March 20, 1985
- 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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Other Clearances by Roseville Medical Laboratoriesu
| K Number | Device Name | ||
|---|---|---|---|
| K850731 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING | Mar 20, 1985 | Substantially Equivalent |
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850737 | TRANSPORT CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850736 | SELECTIVE CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850733 | MULTIPURPOSE CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850735 | ENRICHED CULTURE MEDIUM | Mar 16, 1985 | Substantially Equivalent |