Green Card Bowie-Dick Test (BD115)
Steritec Products, Inc. (A Getinge Company) · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Engelwood
- Advisory committee description
- General Hospital
- Address 1
- 74 Inverness Dr. E.
- Statement or summary
- Summary
- Product code
- JOJ
- Zip code
- 80112
- Applicant
- Steritec Products, Inc. (A Getinge Company)
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- US
- Device name
- Green Card Bowie-Dick Test (BD115)
- Advisory committee
- HO
- Contact
- Chris Muha
- K number
- K250172
- State
- CO
- Date received
- 2025-01-21
- Review advisory committee
- HO
- Postal code
- 80112
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Indicator, Physical/Chemical Sterilization Process
- Medical specialty description
- General Hospital
- Regulation number
- 880.2800
- Device class
- 2
- Registration number
- 1051614, 3010363542, 9610612, 3000268902, 3027234828, 3013298431, 3015392401, 2437780, 3042191618, 3005581832, 3014421917, 3030626857, 3011494162, 3036622014, 3017524825, 1450386, 3036679484, 3021361802, 3010864832, 1720499, 3043226252, 9611959, 3031982553, 2013736, 3004634710, 3001124136, 1941138, 1722021, 3004201548, 3038138452, 3003476474, 3031841433, 2150060, 3016678045, 3029802606, 1417592, 2424472, 3012421607, 3030733800, 3016426851 +89 more
- FEI number
- 1051614, 3010363542, 3000268902, 3027234828, 3013298431, 3015392401, 3042191618, 3005581832, 3014421917, 3030626857, 3011494162, 2523865, 3036622014, 3017524825, 3036679484, 3021361802, 1720499, 3043226252, 1937223, 3031982553, 2013736, 3004634710, 3001124136, 1941138, 3004201548, 3038138452, 3003476474, 3031841433, 2150060, 1000137528, 3008875470, 3016678045, 3029802606, 1417592, 3006442872, 3002677549, 3012421607, 3030733800, 3016426851, 1319130 +89 more