510(k) K801815
- Device
- AUTOLET
- Applicant
- ULSTER SCIENTIFIC, INC.
- 510(k) number
- K801815
- Product code
- JCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-10
- Date received
- 1980-07-30
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | 1985-03-01 |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | American Dade | 1983-03-17 |
| K761250 | SIMPLATE | General Diagnostics | 1977-03-01 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases