510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821154Substantially Equivalent

Kallestad Quantizyme Theophylline Enzyme

Jay Rau, Technical Suppprt, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821154 is the FDA 510(k) clearance record for KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME, a class II device, cleared for Jay Rau, Technical Suppprt on under FDA product code KLS (Enzyme Immunoassay, Theophylline). FDA records list one 510(k) clearance for Jay Rau, Technical Suppprt. As of , FDA records show no recalls naming K821154.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KLS Enzyme Immunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Jay Rau, Technical Suppprt 803 N. Front St. Suite 3, Mchenry IL
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