510(k) K024006 ยท JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Mar 31, 2003 |
| Received | Dec 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2015 | Pointe Scientific, Inc. Pointe Scientific G6PD Controls
Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3).
Also sold as individual vials
Bottle: Clear glass vials
Cap: Rubber seal with colored Terminated |
JBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.