510(k) K760066
K760066 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "TRAY, ICED INJECTABLE (26420)". The FDA issued a decision of Substantially Equivalent on July 21, 1976. The device falls under product code DXL (Injector, Indicator), a Class II device regulated under 21 CFR 870.1660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1976
- Date Received
- June 16, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Indicator
- Device Class
- Class II
- Regulation Number
- 870.1660
- Review Panel
- CV
- Submission Type