Panels › Hematology › Product code GGW · Class 2
Test, Time, Partial Thromboplastin
Regulation 864.7925
1510(k)s in 12 months (32 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GGW
| Company | 510(k)s | Recalls |
|---|---|---|
| American Bioproducts Co. | 4 | 0 |
| Bio/Data Corp. | 3 | 0 |
| Helena Laboratories | 3 | 0 |
| American Dade | 2 | 0 |
| R2 Diagnostics, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Abbott Laboratories | 1 | 0 |
| Aniara Diagnostica, LLC | 1 | 0 |
| Axis-Shield Doc AS | 1 | 0 |
| Biosearch Medical Products, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2013 | Siemens Healthcare Diagnostics, Inc. Dade(R) Actin(R) FSL Activated PTT Reagent.
For use in the determination of the activated partial thromboplastin time (APTT). Terminated |
GGW | K863594 |
| Feb 16, 2012 | Siemens Healthcare Diagnostics, Inc. Dade(R) Actin(R) FSL Activated PTT Reagent
Product Usage:
Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitiv Terminated |
GGW | K863594 |
| Dec 23, 2005 | Dade Behring , Inc. Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100 Terminated |
GGW | K811589 |
| Aug 30, 2005 | Diagnostica Stago, Inc. PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. Terminated |
GGW | K921684 |
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