510(k) K042362 ยท KHS Enzymatic, Carbon-Dioxide
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
| Applicant | Diagnostic Chemicals , Ltd., Charlottetown, P.E., CA |
| Decision | Substantially Equivalent, Dec 27, 2004 |
| Received | Aug 31, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042362
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.