KSE · Refrigerator, Freezer, Blood Storage
Hematology · 21 CFR 864.9700 · Class 2
Overview
| Product Code | KSE |
|---|---|
| Device Name | Refrigerator, Freezer, Blood Storage |
| Regulation | 21 CFR 864.9700 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884436 | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | Harris Mfg. Co. | Dec 2, 1988 | SESE |
| K813327 | SEPCOR TEMPERATURE MONITOR | Separation Science Corp. | Dec 31, 1981 | SESE |
| K802319 | HEMOTEMP TM | Marion Laboratories, Inc. | Oct 10, 1980 | SESE |
| K800667 | MONITEMP BLOOD PACK TEMP. MONITOR | Liquid Crystal Products, Inc. | Apr 16, 1980 | SESE |
Top Applicants
- Harris Mfg. Co. — 1 clearance
- Liquid Crystal Products, Inc. — 1 clearance
- Marion Laboratories, Inc. — 1 clearance
- Separation Science Corp. — 1 clearance
