510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885097Substantially Equivalent

Acetaminophen (Enzymatic Rate), Number 502-13

Diagnostic Chemicals, Ltd. (USA), Monroe CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885097 is the FDA 510(k) clearance record for ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13, a class II device, cleared for Diagnostic Chemicals, Ltd. (Usa) on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 77 510(k) clearances for Diagnostic Chemicals, Ltd. (Usa), from to . As of , FDA records show no recalls naming K885097.

Clearance record

Decision date
Received
(33 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Chemicals, Ltd. (Usa) 435 Main St., Monroe CT
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