510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952596Substantially Equivalent

Theophylline Enzyme Immunoassay

Diagnostic Reagents, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952596 is the FDA 510(k) clearance record for THEOPHYLLINE ENZYME IMMUNOASSAY, a class II device, cleared for Diagnostic Reagents, Inc. on under FDA product code KLS (Enzyme Immunoassay, Theophylline). FDA records list 66 510(k) clearances for Diagnostic Reagents, Inc., from to . As of , FDA records show no recalls naming K952596.

Clearance record

Decision date
Received
(66 days to decision)
Product code
KLS Enzyme Immunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Reagents, Inc. 601 California Ave., Sunnyvale CA
510(k) summary
Statement
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