510(k) K002177 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
| Applicant | Haemoscope Corp., Skokie IL, US |
| Decision | Substantially Equivalent, Sep 14, 2000 |
| Received | Jul 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2022 | Haemonetics Corporation TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 Terminated |
JPA | None listed |
| Apr 19, 2022 | Haemonetics Corporation Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -
PlateletMapping ADP & AA (07-014),
PlateletMapping ADP (07-015),
Platelet Terminated |
JPA | None listed |
| Feb 19, 2020 | Haemonetics Corporation TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1.
Intended: For in vitro coagulation studies Terminated |
JPA | None listed |
| Feb 19, 2015 | Haemonetics Corporation Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002.
Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System. Terminated |
JPA | None listed |
| Jul 24, 2013 | Haemonetics Corporation TEG 5000 Thromboelastograph Coagulation Analyzer
Product Usage:
Multipurpose System for In Vitro Coagulation Studies Terminated |
JPA | None listed |
| Jul 6, 2011 | Haemoscope Division of Haemonetics Corp TEG Hemostasis System Level II Control:
Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series
Used as the operational check and calibration verification f Terminated |
JPA | None listed |
| Mar 21, 2011 | Haemoscope Division of Haemonetics Corp TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022
a multipurpose syst Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.