Cleared Traditional

K963694 - EASYLYTE CALCIUM/CHLORIDE ANALYZER

K963694 is the FDA 510(k) clearance for EASYLYTE CALCIUM/CHLORIDE ANALYZER by Medica Corp.. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K963694 · Medica Corp. · Chemistry device
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Nov 1996
Decision
72d
Days
Class 2
Risk

K963694 is an FDA 510(k) clearance for the EASYLYTE CALCIUM/CHLORIDE ANALYZER. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Medica Corp. devices

Submission Details

510(k) Number K963694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date November 27, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 10
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