510(k) K984361 ยท PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
ORAL-EZE ORAL FLUID COLLECTION SYSTEM
| Applicant | Osborn Laboratories, Inc., Olathe KS, US |
| Decision | Substantially Equivalent, Jan 13, 1999 |
| Received | Dec 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2012 | Capitol Vial Inc Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832
Product Usage:
IVD for drugs of abuse Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.