HEMOTEMP TM
FDA 510(k) clearance K802319 · decided 1980-10-10
Clearance details
- K-number
- K802319
- Device name
- HEMOTEMP TM
- Applicant
- Marion Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-23
- Decision date
- 1980-10-10
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KSE
- Device class
- 2
- Regulation number
- 864.9700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Marion Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (K884436) | Harris Mfg. Co. | 1988-12-02 |
| SEPCOR TEMPERATURE MONITOR (K813327) | Separation Science Corp. | 1981-12-31 |
| MONITEMP BLOOD PACK TEMP. MONITOR (K800667) | Liquid Crystal Products, Inc. | 1980-04-16 |
Recalls involving this device
No recalls on record reference this clearance.