Sepcor Temperature Monitor
FDA 510(k) K813327 · Separation Science Corp.
510(k) numberK813327
Submission
- Device name
- Sepcor Temperature Monitor
- Applicant
- Separation Science Corp.
Walker, MI, US - Received
- November 24, 1981
- Decision date
- December 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSE – Refrigerator, Freezer, Blood Storage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9700
- Specialty
- Hematology
Other 510(k)s with product code KSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884436 | Modified Low-Temp. Freezer Model HLT-80LS-85KSE · Traditional | Harris Mfg. Co. | 12/02/1988SE |
| K802319 | Hemotemp TMKSE · Traditional | Marion Laboratories, Inc. | 10/10/1980SE |
| K800667 | Monitemp Blood Pack Temp. MonitorKSE · Traditional | Liquid Crystal Products, Inc. | 04/16/1980SE |
More from Liquid Crystal Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820712 | Sepcor Unit Collection MonitorKSQ · Traditional | 05/07/1982SE |
Questions and answers
When was Sepcor Temperature Monitor cleared by the FDA?
Sepcor Temperature Monitor (K813327) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 37 days after the submission was received.
What is the product code of K813327?
The FDA product code is KSE – Refrigerator, Freezer, Blood Storage, a Class II (moderate risk) device regulated under 21 CFR 864.9700.