Panels › Hematology › Product code JCA · Class 2
Device, Bleeding Time
Regulation 864.6100
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JCA
| Company | 510(k)s | Recalls |
|---|---|---|
| International Technidyne Corp. | 2 | 0 |
| American Dade | 1 | 0 |
| General Diagnostics | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| ITC-Nexus Dx | 0 | 1 |
| Organon Teknika Corp. | 1 | 0 |
| Ulster Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1991 | K911745 | SIMPLATE PEDIATRIC Organon Teknika Corp. | JCA |
| Jul 17, 1991 | K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION International Technidyne Corp. | JCA |
| Jun 10, 1987 | K871318 | Q.I.C. BLEEDING TIME DEVICE Helena Laboratories | JCA |
| Mar 1, 1985 | K850542 | SURGICUTT - BLEEDING TIME DEVICE International Technidyne Corp. | JCA |
| Mar 17, 1983 | K830645 | BLEEDING TIME DEVICE DISPOSABLE American Dade | JCA |
| Oct 10, 1980 | K801815 | AUTOLET Ulster Scientific, Inc. | JCA |
| Mar 1, 1977 | K761250 | SIMPLATE General Diagnostics | JCA |
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