510(k) K122584 ยท GJS Test, Time, Prothrombin
HEMOSIL READIPLAS TIN
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Mar 24, 2013 |
| Received | Aug 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2022 | Instrumentation Laboratory HemosIL ReadiPlasTin, Part No. 0020301400 Open, Classified |
GJS | None listed |
| Nov 23, 2021 | Instrumentation Laboratory HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. Open, Classified |
GJS | None listed |
| Aug 1, 2018 | Instrumentation Laboratory Co. Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the qu Terminated |
GJS | None listed |
| Mar 3, 2018 | Instrumentation Laboratory Co. Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.