Cleared Traditional

URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR

K934843 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Mar 1994
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K934843 is an FDA 510(k) clearance for the URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 11, 1994, 154 days after receiving the submission on October 8, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K934843 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1993
Decision Date March 11, 1994
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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