510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821969Substantially Equivalent

Acetaminophen Stat-Pak Reagent Set

Clin Tech Diagnostics Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821969 is the FDA 510(k) clearance record for ACETAMINOPHEN STAT-PAK REAGENT SET, a class II device, cleared for Clin Tech Diagnostics Corp. on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 5 510(k) clearances for Clin Tech Diagnostics Corp., from to . As of , FDA records show no recalls naming K821969.

Clearance record

Decision date
Received
(15 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Clin Tech Diagnostics Corp. 803 N. Front St. Suite 3, Mchenry IL
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