Product code KSE
- Device name
- Refrigerator, Freezer, Blood Storage
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9700
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884436 | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | Harris Mfg. Co. | 1988-12-02 |
| K813327 | SEPCOR TEMPERATURE MONITOR | Separation Science Corp. | 1981-12-31 |
| K802319 | HEMOTEMP TM | Marion Laboratories, Inc. | 1980-10-10 |
| K800667 | MONITEMP BLOOD PACK TEMP. MONITOR | Liquid Crystal Products, Inc. | 1980-04-16 |
Related GUDID Devices#
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|---|---|---|---|
| 10815236021050 | HemoTemp | LCR HALLCREST, LLC. | 2022-06-20 |
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