510(k) K871318
- Device
- Q.i.c. Bleeding Time Device
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K871318
- Product code
- JCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-10
- Date received
- 1987-04-03
- Regulation
- 864.6100
- Classification name
- Device, Bleeding Time
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3002721930
- 3014150341
- 2029275
- 1217183
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911745 | SIMPLATE PEDIATRIC | Organon Teknika Corp. | 1991-08-09 |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | 1991-07-17 |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | 1985-03-01 |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | American Dade | 1983-03-17 |
| K801815 | AUTOLET | Ulster Scientific, Inc. | 1980-10-10 |
| K761250 | SIMPLATE | General Diagnostics | 1977-03-01 |