510(k) K062361 ยท JHI Visual, Pregnancy Hcg, Prescription Use
INNOVACON HCG UKTRA TEST DEVICE
| Applicant | Innovacon, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 23, 2006 |
| Received | Aug 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. 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-Vue Serum/UrinehCG-STAT, Model/ Part: FHC- Open, Classified |
JHI | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002.
b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test Open, Classified |
JHI | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210.
b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Open, Classified |
JHI | None listed |
| May 25, 2013 | Alere San Diego, Inc. Alere" hCG Combo Cassette (20/10 mIU/mL) Kit.
Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonado Terminated |
JHI | None listed |
| May 6, 2008 | Innovacon Inc Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Di Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.