510(k) K980120 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
DIGENE DML 2000 MICROPLATE LUMINOMETER
| Applicant | Digene Corp., Beltsville MD, US |
| Decision | Substantially Equivalent, Feb 6, 1998 |
| Received | Jan 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2011 | QIAGEN Gaithersburg, Inc. Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A.
The software ca Terminated |
JJQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.