510(k) K974302 ยท GNW Antisera, Cf, Influenza Virus A, B, C
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
| Applicant | Light Diagnostics, Temecula CA, US |
| Decision | Substantially Equivalent, Apr 8, 1998 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2009 | Millipore Corporation LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit
Immunofluorescence Assay
Cat. No. 3121
FOR IN VITRO DIAGNOSTIC USE
Authorized Representative:
Millipore (UK) Ltd.
Fleming Road,
Kirkton Campus
L Terminated |
GNW | None listed |
| Mar 6, 2009 | Millipore Corporation LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit. Terminated |
GNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.