510(k) K011161 ยท LCM Enzyme Immunoassay, Phencyclidine
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 15, 2001 |
| Received | Apr 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011161
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.