510(k) K130157 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
| Applicant | Aalto Scientific, Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 19, 2013 |
| Received | Jan 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130157
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.