510(k) K021024 ยท GGN Plasma, Coagulation Control
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 16, 2002 |
| Received | Mar 29, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2013 | Instrumentation Laboratory Co. HemosIL Normal Control 1 UNASSAYED
Part Number: 0020003120 Terminated |
GGN | None listed |
| Dec 16, 2013 | Instrumentation Laboratory Co. HemosIL Low Abnormal Control 2 UNASSAYED
Part Number: 0020003220 Terminated |
GGN | None listed |
| Dec 16, 2013 | Instrumentation Laboratory Co. HemosIL High Abnormal Control 3 UNASSAYED
Part Number: 0020003320 Terminated |
GGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.