510(k) K014008 ยท GFO Activated Partial Thromboplastin
HEMOCHRON JR. CITRATE APTT CUVETTE
| Applicant | Itc, Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Jan 24, 2002 |
| Received | Dec 5, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2014 | ITC-Nexus Dx Hemochron Jr. Citrate APTT Cuvette
510(k) K014008
A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of lo Terminated |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.