510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931257Substantially Equivalent

Acetasite

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

K931257 is the FDA 510(k) clearance record for ACETASITE, a class II device, cleared for Gds Diagnostics on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 4 510(k) clearances for Gds Diagnostics, from to . As of , FDA records show no recalls naming K931257.

Clearance record

Decision date
Received
(118 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Gds Diagnostics 25235 Leer Dr., Elkhart IN
510(k) summary
Statement
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