FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRANSPORT CULTURE MEDIUM
K Number: K850737
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
258
Registration Numbers
258
Same Product Code
15
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- TRANSPORT CULTURE MEDIUM
- K Number
- K850737
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Roseville Medical Laboratoriesu
- Date Received
- February 20, 1985
- Decision Date
- March 20, 1985
- Product Code
- PPM
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| PPM | General Purpose Reagent | FDA class 1 | Pathology |
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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 |
| K850736 | SELECTIVE CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850733 | MULTIPURPOSE CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850732 | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI | Mar 20, 1985 | Substantially Equivalent |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Mar 20, 1985 | Substantially Equivalent |
| K850735 | ENRICHED CULTURE MEDIUM | Mar 16, 1985 | Substantially Equivalent |