FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
K Number: K103805
·
Decision Jan 25, 2011
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
- K Number
- K103805
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Wire & Equipment Company (Bath), Ltd.
- Date Received
- December 28, 2010
- Decision Date
- January 25, 2011
- Product Code
- LIO
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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