510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884358Substantially Equivalent

Cedia Theophylline Assay

Microgenics Corporation, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884358 is the FDA 510(k) clearance record for CEDIA THEOPHYLLINE ASSAY, a class II device, cleared for Microgenics Corp. on under FDA product code KLS (Enzyme Immunoassay, Theophylline). FDA records list 128 510(k) clearances for Microgenics Corp., from to . As of , FDA records show no recalls naming K884358.

Clearance record

Decision date
Received
(113 days to decision)
Product code
KLS Enzyme Immunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corp. 2380a Bisso Ln., Concord CA
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