510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933258Substantially Equivalent

Vidas Theophylline(theo)

Biomerieux Vitek, Inc., Rockland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933258 is the FDA 510(k) clearance record for VIDAS THEOPHYLLINE(THEO), a class II device, cleared for Biomerieux Vitek, Inc. on under FDA product code KLS (Enzyme Immunoassay, Theophylline). FDA records list 49 510(k) clearances for Biomerieux Vitek, Inc., from to . As of , FDA records show no recalls naming K933258.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KLS Enzyme Immunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Biomerieux Vitek, Inc. 1022 Hingham St., Rockland MA
510(k) summary
Summary
Third party review
No

Clearances, product code KLS

Trailing 12 months

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

FDA records show no clearances under product code KLS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLS, 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