510(k) K060930 ยท KHE Reagent, Occult Blood
INSURE II
| Applicant | Enterix, Inc., Edison NJ, US |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Apr 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2008 | Enterix, Inc. INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits.
Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.