Refrigerator, Freezer, Blood Storage
This device is a blood storage refrigerator or freezer used to maintain whole blood, red blood cell concentrates, plasma, and other blood components at required temperatures to preserve viability and sterility prior to transfusion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSE, regulated under 21 CFR 864.9700 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSE
- Device Class
- FDA class 2
- Regulation Number
- 864.9700
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884436 | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | Dec 02, 1988 | Substantially Equivalent | Harris Mfg. Co. |
| K813327 | SEPCOR TEMPERATURE MONITOR | Dec 31, 1981 | Substantially Equivalent | Separation Science Corp. |
| K802319 | HEMOTEMP TM | Oct 10, 1980 | Substantially Equivalent | Marion Laboratories, Inc. |
| K800667 | MONITEMP BLOOD PACK TEMP. MONITOR | Apr 16, 1980 | Substantially Equivalent | Liquid Crystal Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.