510(k) K822397 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
ANA HEP-2 FLUORO-KIT
| Applicant | Clinical Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 21, 1982 |
| Received | Aug 10, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2005 | Diasorin Inc. Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test. Terminated |
DHN | None listed |
| Apr 6, 2005 | Diasorin Inc. PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Tes Terminated |
DHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.