510(k) K894366 ยท LBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Aug 31, 1989 |
| Received | Jul 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894366
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.