510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792062Substantially Equivalent

Theophylline Riassay

Ria Diagnostics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792062 is the FDA 510(k) clearance record for THEOPHYLLINE RIASSAY, a class II device, cleared for Ria Diagnostics on under FDA product code LCA (Radioimmunoassay, Theophylline). FDA records list 7 510(k) clearances for Ria Diagnostics, from to . As of , FDA records show no recalls naming K792062.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LCA Radioimmunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ria Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LCA

Trailing 12 months

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

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