510(k) K934843
K934843 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1994
- Date Received
- October 8, 1993
- 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