510(k) K043378 ยท JIT Calibrator, Secondary
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
| Applicant | Drew Scientific , Ltd., Barrow In Furness Cumbria, GB |
| Decision | Substantially Equivalent, Dec 29, 2004 |
| Received | Dec 8, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043378
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.