Cleared Traditional

K844021 - ISE REAGENTS FOR DEMAND ANALYZER

K844021 is the FDA 510(k) clearance for ISE REAGENTS FOR DEMAND ANALYZER by Advanced Biomedical Methods, Inc.. It is a Class 2 Chemistry device (product code CGZ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844021 · Advanced Biomedical Methods, Inc. · Chemistry device
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Dec 1984
Decision
56d
Days
Class 2
Risk

K844021 is an FDA 510(k) clearance for the ISE REAGENTS FOR DEMAND ANALYZER. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Advanced Biomedical Methods, Inc. (Niles, US). The FDA issued a Cleared decision on December 10, 1984 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 Advanced Biomedical Methods, Inc. devices

Submission Details

510(k) Number K844021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1984
Decision Date December 10, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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.