Cleared Traditional

K920223 - CHEM CHEX THEOPHYLLINE CONTROL (FDA 510(k) Clearance)

Class I Toxicology device.

K920223 · Streck Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
145d
Days
Class 1
Risk

K920223 is an FDA 510(k) clearance for the CHEM CHEX THEOPHYLLINE CONTROL. Classified as Theophylline Control Materials (product code LAW), Class I - General Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K920223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date June 10, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 87d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAW Theophylline Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.