510(k) K982100 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Dec 20, 1999 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | The Binding Site Group, Ltd. MininephThl Human lgG4 Kit
Product Code: ZK009.LR
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of th Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.