510(k) clearance
Instant-View® hCG Combo II Cassette Test
- 510(k) number
- K262299
- Applicant
- Alfa Scientific Designs, Inc.
- Decision date
- Sep 22, 2026
- Date received
- Jul 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JHI
- Device type
- Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II
- Regulation
- 21 CFR 862.1155
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Powat, CA, US