510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945338Substantially Equivalent

Theophylline Calibrators

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

K945338 is the FDA 510(k) clearance record for THEOPHYLLINE CALIBRATORS, a class II device, cleared for Diagnostic Reagents, Inc. on under FDA product code DLJ (Calibrators, Drug Specific). FDA records list 66 510(k) clearances for Diagnostic Reagents, Inc., from to . As of , FDA records show no recalls naming K945338.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DLJ Calibrators, Drug Specific
Regulation
21 CFR 862.3200
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Reagents, Inc. 110 Pioneer Way, Mountain View CA
510(k) summary
Statement
Third party review
No

Clearances, product code DLJ

Trailing 12 months

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

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