510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920223Substantially Equivalent

Chem Chex Theophylline Control

Streck Laboratories, Inc., Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920223 is the FDA 510(k) clearance record for CHEM CHEX THEOPHYLLINE CONTROL, a class I device, cleared for Streck Laboratories, Inc. on under FDA product code LAW (Theophylline Control Materials). FDA records list 70 510(k) clearances for Streck Laboratories, Inc., from to . As of , FDA records show no recalls naming K920223.

Clearance record

Decision date
Received
(145 days to decision)
Product code
LAW Theophylline Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Streck Laboratories, Inc. 14306 Industrial Rd., Omaha NE
510(k) summary
Summary
Third party review
No

Clearances, product code LAW

Trailing 12 months

FDA records hold no clearances under product code LAW in the trailing twelve months.

FDA records show no clearances under product code LAW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260