510(k) K894057 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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| Applicant | Photec Diagnostics, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 31, 1989 |
| Received | Jun 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894057
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.