Device type
Visual, Pregnancy Hcg, Prescription Use
Product code JHI · Class II · 21 CFR 862.1155 · Clinical Chemistry
Recent 510(k)s
Sep 22, 2026
K262299
Instant-View® hCG Combo II Cassette Test
Alfa Scientific Designs, Inc.
- JHI
- Class II
Recent recalls
Oct 7, 2026
Z-3272-2026
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Hen…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing
Oct 7, 2026
Z-3274-2026
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing
Oct 7, 2026
Z-3271-2026
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-V…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing
Oct 7, 2026
Z-3273-2026
Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henr…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing