Cleared Traditional

K920223 - CHEM CHEX THEOPHYLLINE CONTROL

K920223 is an FDA 510(k) clearance for CHEM CHEX THEOPHYLLINE CONTROL, manufactured by Streck Laboratories, Inc.. The device is a Class 1 Toxicology device with product code LAW cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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

FDA 510(k) Submission Details - K920223

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 87d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

LAW Device Classification - Class 1, General Controls

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.