510(k) K012295 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser
Product Code: NK009.T
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in s Terminated |
CFN | None listed |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG Subclass Liquid Reagent Kits for use on the
Siemens BN"IJ Analyser
Product Code: NK001.T
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.