Cleared Traditional

K943704 - LIPASE CALIBRATOR

K943704 is an FDA 510(k) clearance for LIPASE CALIBRATOR, manufactured by The DU Pont Co.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K943704 · The DU Pont Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
44d
Days
Class 2
Risk

K943704 is an FDA 510(k) clearance for the LIPASE CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on September 14, 1994 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The DU Pont Co. devices

FDA 510(k) Submission Details - K943704

510(k) Number K943704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date September 14, 1994
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 174
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