510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880829Substantially Equivalent

Gds Enzymatic Acetaminophen Reagent

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

K880829 is the FDA 510(k) clearance record for GDS ENZYMATIC ACETAMINOPHEN REAGENT, a class II device, cleared for Gds Technology, LLC on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 8 510(k) clearances for Gds Technology, LLC, from to . As of , FDA records show no recalls naming K880829.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Gds Technology, LLC 25235 Leer Dr., Elkhart IN
Third party review
No

Clearances, product code LDP

Trailing 12 months
1 clearance under product code LDP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260