MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
FDA 510(k) clearance K884436 · decided 1988-12-02
Clearance details
- K-number
- K884436
- Device name
- MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
- Applicant
- Harris Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-21
- Decision date
- 1988-12-02
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KSE
- Device class
- 2
- Regulation number
- 864.9700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Trenton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SEPCOR TEMPERATURE MONITOR (K813327) | Separation Science Corp. | 1981-12-31 |
| HEMOTEMP TM (K802319) | Marion Laboratories, Inc. | 1980-10-10 |
| MONITEMP BLOOD PACK TEMP. MONITOR (K800667) | Liquid Crystal Products, Inc. | 1980-04-16 |
Recalls involving this device
No recalls on record reference this clearance.