510(k) K981200 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
IL TEST PLASMINOGEN
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, May 26, 1998 |
| Received | Apr 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2016 | Instrumentation Laboratory Co. HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.