FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Green Card Bowie-Dick Test (BD115)
K Number: K250172
·
Decision Feb 20, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
262
Applicant Total
1
Review Days
30
Basic Information
- Device Name
- Green Card Bowie-Dick Test (BD115)
- K Number
- K250172
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SteriTec Products, Inc. (a Getinge Company)
- Date Received
- January 21, 2025
- Decision Date
- February 20, 2025
- Product Code
- JOJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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