510(k) BK960072
- Device
- Blood Storage Refrigerators And Freezers
- Applicant
- Thermogenesis
- 510(k) number
- BK960072
- Product code
- KSE
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1999-02-12
- Date received
- 1996-09-13
- Regulation
- 864.9700
- Classification name
- Refrigerator, Freezer, Blood Storage
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSE #
| 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 |
Legacy Summary#
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FDA Review#
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