510(k) K850542
- Device
- SURGICUTT - BLEEDING TIME DEVICE
- Applicant
- INTERNATIONAL TECHNIDYNE CORP.
- 510(k) number
- K850542
- Product code
- JCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-01
- Date received
- 1985-02-11
- 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
- MICHAEL D MINTZ
- Address
- 23 Nevsky St. Edison NJ US 08820 08820
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 |
| K871318 | Q.I.C. BLEEDING TIME DEVICE | Helena Laboratories | 1987-06-10 |
| 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 |
Legacy Summary#
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FDA Review#
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