Hemotemp TM
FDA 510(k) K802319 · Marion Laboratories, Inc.
510(k) numberK802319
Submission
- Device name
- Hemotemp TM
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- September 23, 1980
- Decision date
- October 10, 1980
- 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 |
| K813327 | Sepcor Temperature MonitorKSE · Traditional | Separation Science Corp. | 12/31/1981SE |
| K800667 | Monitemp Blood Pack Temp. MonitorKSE · Traditional | Liquid Crystal Products, Inc. | 04/16/1980SE |
More from Liquid Crystal Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Hemotemp TM cleared by the FDA?
Hemotemp TM (K802319) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 17 days after the submission was received.
What is the product code of K802319?
The FDA product code is KSE – Refrigerator, Freezer, Blood Storage, a Class II (moderate risk) device regulated under 21 CFR 864.9700.