510(k) K940486 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
DIGENE DCR-1 LUMINOMETER
| Applicant | Digene Diagnostics, Inc., Silver Spring MD, US |
| Decision | Substantially Equivalent, Apr 18, 1995 |
| Received | Feb 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940486
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.