Cleared Traditional

K923793 - DOCUMENT CHEM III CALIBRATION VERIFICAT...

K923793 is the FDA 510(k) clearance for DOCUMENT CHEM III CALIBRATION VERIFICAT... by Casco Standards. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K923793 · Casco Standards · Chemistry device
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Nov 1992
Decision
100d
Days
Class 1
Risk

K923793 is an FDA 510(k) clearance for the DOCUMENT CHEM III CALIBRATION VERIFICATION TEST. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on November 5, 1992 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Casco Standards devices

Submission Details

510(k) Number K923793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date November 05, 1992
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 371
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