Cleared Traditional

DUPONT LIPASE CALIBRATOR

K952815 · Dupont Medical Products · Chemistry
Aug 1995
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K952815 is an FDA 510(k) clearance for the DUPONT LIPASE CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Dupont Medical Products (Newark, US). The FDA issued a Cleared decision on August 31, 1995, 72 days after receiving the submission on June 20, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K952815 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1995
Decision Date August 31, 1995
Days to Decision 72 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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