Panels › Hematology › Product code GIT · Class 2
Reagent & Control, Partial Thromboplastin Time
Regulation 864.7925
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GIT
| Company | 510(k)s | Recalls |
|---|---|---|
| Biotrack, Inc. | 1 | 0 |
| Creative Laboratory Products, Inc. | 1 | 0 |
| Organon Teknika Corp. | 1 | 0 |
| Pacific Hemostasis | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 1989 | K890051 | BIOTRACK APTT CONTROLS Biotrack, Inc. | GIT |
| Aug 17, 1988 | K881999 | PLATELIN(R) EXCEL L Organon Teknika Corp. | GIT |
| Mar 18, 1988 | K880711 | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. Creative Laboratory Products, Inc. | GIT |
| Mar 26, 1982 | K820450 | THROMBOSCREEN Pacific Hemostasis | GIT |
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