FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K Number: K013819
·
Decision Feb 28, 2002
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
1
Review Days
104
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Basic Information
- Device Name
- URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
- K Number
- K013819
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sierra Diagnostic, LLC
- Date Received
- November 16, 2001
- Decision Date
- February 28, 2002
- Product Code
- JTW
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | FDA class 1 | Microbiology |
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