510(k) K851393
K851393 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT PREP FOUR-SOLVENT RETROFIT KIT". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. 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
- July 12, 1985
- Date Received
- April 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clinical Sample Concentrator
- Device Class
- Class I
- Regulation Number
- 862.2310
- Review Panel
- CH
- Submission Type