510(k) K081217 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, May 22, 2008 |
| Received | Apr 30, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2018 | Hycor Biomedical LLC HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA Open, Classified |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.