510(k) K882117 ยท DNN Calibrators, Ethyl Alcohol
ETHYL ALCOHOL STANDARD
| Applicant | Verichem Laboratories, Inc., Providence RI, US |
| Decision | Substantially Equivalent, Aug 4, 1988 |
| Received | May 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2007 | Mega Diagnostics Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials. Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD. Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD. Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.