Cleared Traditional

K842848 - CODE-A-WELL 350 MICROTITRATION STRIPS

K842848 is the FDA 510(k) clearance for CODE-A-WELL 350 MICROTITRATION STRIPS by Plastic Injectors, Inc.. It is a Class 1 Chemistry device (product code JTC) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842848 · Plastic Injectors, Inc. · Chemistry device
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Sep 1984
Decision
49d
Days
Class 1
Risk

K842848 is an FDA 510(k) clearance for the CODE-A-WELL 350 MICROTITRATION STRIPS. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Plastic Injectors, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2500 - 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 Plastic Injectors, Inc. devices

Submission Details

510(k) Number K842848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date September 07, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTC Device, Microtiter Diluting/dispensing

All 30
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