510(k) K090920 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Dec 30, 2009 |
| Received | Apr 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090920
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P
Product Code LK009.H/LK001.H
This kit i Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.