510(k) K944691 ยท GGN Plasma, Coagulation Control
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Mar 15, 1995 |
| Received | Sep 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944691
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2010 | International Technidyne Corp. International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic
15 vials
For performance of Level 1 qualit Terminated |
GGN | None listed |
| Jul 28, 2010 | International Technidyne Corporation GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:
IVD. 15/pk. 06260061600.
Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125.
Intended to be used Terminated |
GGN | None listed |
| Jul 28, 2010 | International Technidyne Corporation GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk.
Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125.
Intended to be used t Terminated |
GGN | None listed |
| Jun 11, 2010 | International Technidyne Corporation directCHECK Whole Blood Control;
for Hemochron J. Microcoagulation Systems. Terminated |
GGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.