510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843839Substantially Equivalent

Stat/pb Reagent

Tri-Tech, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843839 is the FDA 510(k) clearance record for STAT/PB REAGENT, a class II device, cleared for Tri-Tech, Inc. on under FDA product code DOF (Lead, Atomic Absorption). FDA records list 11 510(k) clearances for Tri-Tech, Inc., from to . As of , FDA records show no recalls naming K843839.

Clearance record

Decision date
Received
(94 days to decision)
Product code
DOF Lead, Atomic Absorption
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Tri-Tech, Inc. 5120 Revere Rd., Durham NC
Third party review
No

Clearances, product code DOF

Trailing 12 months

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

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