510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891761Substantially Equivalent

Gds Enzymatic Theophylline Reagent

Gds Diagnostics, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891761 is the FDA 510(k) clearance record for GDS ENZYMATIC THEOPHYLLINE REAGENT, a class II device, cleared for Gds Diagnostics on under FDA product code LCY (U.V. Spectrometry, Theophylline). FDA records list 4 510(k) clearances for Gds Diagnostics, from to . As of , FDA records show no recalls naming K891761.

Clearance record

Decision date
Received
(53 days to decision)
Product code
LCY U.V. Spectrometry, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Gds Diagnostics 25235 Leer Dr., Elkhart IN
Third party review
No

Clearances, product code LCY

Trailing 12 months

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

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