510(k) K990516 ยท DNN Calibrators, Ethyl Alcohol
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
| Applicant | Emd Chemicals, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Mar 31, 1999 |
| Received | Feb 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | EMD Chemicals Inc EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;
1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic. Terminated |
DNN | None listed |
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Terminated |
LCH | None listed |
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 Terminated |
LCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.