510(k) K813592 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
QUANTAFLUOR FLUORESCENT TEST REAGENTS
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 18, 1982 |
| Received | Dec 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2011 | Bio-Rad Laboratories "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN"
The test kit contains slides and substrate.
For use as an indirect fluorescent antibody procedure for the d Terminated |
DHN | None listed |
| Sep 19, 2008 | Bio-Rad Laboratories Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, Terminated |
DHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.