510(k) K800667
K800667 is an FDA 510(k) premarket notification submitted by Liquid Crystal Products, Inc. for the device "MONITEMP BLOOD PACK TEMP. MONITOR". The FDA issued a decision of Substantially Equivalent on April 16, 1980. The device falls under product code KSE (Refrigerator, Freezer, Blood Storage), a Class II device regulated under 21 CFR 864.9700. Liquid Crystal Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1980
- Date Received
- March 26, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Refrigerator, Freezer, Blood Storage
- Device Class
- Class II
- Regulation Number
- 864.9700
- Review Panel
- HE
- Submission Type