510(k) K943704
K943704 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "LIPASE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. The DU Pont Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1994
- Date Received
- August 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Secondary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type