510(k) K042152 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
BINDING SITE IGG SUBLCASS OLYMPUS KITS
| Applicant | The Binding Site, Santa Monica CA, US |
| Decision | Substantially Equivalent, Nov 22, 2004 |
| Received | Aug 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | The Binding Site Group, Ltd. Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser
Product Code LK009.IM
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckma Terminated |
CFN | None listed |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass kit for use on the Beckman Coulter AU"
series
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaure Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.