FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Assure Tech., LLC · Clinical Chemistry
Open FDA's page for this record- Third party flag
- N
- City
- Wilmington
- Advisory committee description
- Clinical Chemistry
- Address 1
- 1521 Concord Pike, Suite 201
- Statement or summary
- Summary
- Product code
- LCX
- Zip code
- 19803
- Applicant
- Assure Tech., LLC
- Decision date
- 2025-02-13
- Decision code
- SESE
- Country code
- US
- Device name
- FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- Advisory committee
- CH
- Contact
- Shisheng Ling
- K number
- K250117
- State
- DE
- Date received
- 2025-01-16
- Review advisory committee
- CH
- Postal code
- 19803
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1155
- Device class
- 2
- Registration number
- 3008054239, 8043323, 3007838093, 3043127647, 3009526336, 3013332582, 3010879605, 3016447251, 3017904598, 3024753119, 3021562175, 2025099, 2531491, 3006635320, 3010220539, 3003741676, 3005569927, 3003917514, 3008808560, 3027500452, 3018786392, 3010131137, 1417592, 3013501873, 3005360469, 3006479639, 3006305917, 3007154442, 3030648160, 3028107593, 3009414546, 3004635103, 3007583565, 3038560224, 3031664550, 3008852306, 3033507883, 3030531253, 3014171027, 1649661 +85 more
- FEI number
- 3008054239, 3007838093, 3043127647, 3009526336, 3013332582, 3010879605, 3003102569, 3006078362, 3016447251, 3017904598, 3024753119, 3021562175, 3006635320, 3010220539, 3003741676, 3005569927, 3003917514, 3003075526, 3027500452, 3018786392, 1000118544, 3010131137, 3007981058, 1417592, 3013501873, 3006479639, 3006305917, 3007154442, 3030648160, 3028107593, 3009414546, 3004635103, 3007583565, 3038560224, 3031664550, 3008852306, 3033507883, 3030531253, 3001452245, 3003516723 +85 more