510(k) K010599 ยท GJS Test, Time, Prothrombin
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jul 2, 2001 |
| Received | Feb 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2013 | Assuramed ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Prot Terminated |
GJS | None listed |
| Feb 19, 2013 | International Technidyne Corp. Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50.
International Technidyne Corporation.
The Pro Time Microcoagulation System is a portable battery operated instrume Terminated |
GJS | None listed |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.