510(k) K851393

DUPONT PREP FOUR-SOLVENT RETROFIT KIT by E.I. Dupont DE Nemours & Co., Inc. — Product Code JJH

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