510(k) K934843

URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code JIT

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