Autolet
FDA 510(k) K801815 · Ulster Scientific, Inc.
510(k) numberK801815
Submission
- Device name
- Autolet
- Applicant
- Ulster Scientific, Inc.
Mchenry, IL, US - Received
- July 30, 1980
- Decision date
- October 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCA – Device, Bleeding Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6100
- Specialty
- Hematology
Other 510(k)s with product code JCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911745 | Simplate PediatricJCA · Traditional | Organon Teknika Corp. | 08/09/1991SE |
| K911996 | Surgicutt-Bleeding Time Device, ModificationJCA · Traditional | International Technidyne Corp. | 07/17/1991SE |
| K871318 | Q.I.C. Bleeding Time DeviceJCA · Traditional | Helena Laboratories | 06/10/1987SE |
| K850542 | Surgicutt - Bleeding Time DeviceJCA · Traditional | International Technidyne Corp. | 03/01/1985SE |
| K830645 | Bleeding Time Device DisposableJCA · Traditional | American Dade | 03/17/1983SE |
| K761250 | SimplateJCA · Traditional | General Diagnostics | 03/01/1977SE |
More from General Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K942620 | Feather-Touch Single-Stick DeviceFMK · Traditional | 06/22/1994SE |
| K920562 | UnistikFMK · Traditional | 03/27/1992SE |
| K902592 | Epc Electronic Pipetting SystemJQW · Traditional | 07/19/1990SE |
| K895890 | AutopenFMF · Traditional | 02/16/1990SE |
| K894474 | The Autolet LiteFMK · Traditional | 08/18/1989SE |
| K885340 | Air Displacement PipetteJQW · Traditional | 02/14/1989SE |
| K875354 | Unistep Capillary Blood Collection SystemLCP · Traditional | 02/17/1988SE |
| K871571 | Neurotips(Tm)GXB · Traditional | 06/18/1987SE |
| K871076 | WinpetteJPH · Traditional | 03/23/1987SE |
| K870078 | Accupen(R)FMF · Traditional | 03/17/1987SE |
Questions and answers
When was Autolet cleared by the FDA?
Autolet (K801815) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 72 days after the submission was received.
What is the product code of K801815?
The FDA product code is JCA – Device, Bleeding Time, a Class II (moderate risk) device regulated under 21 CFR 864.6100.