Cleared Traditional

NITRO BLUE TETRAZOLIUM REDUCTION

K904022 · Sigma Chemical Co. · Pathology
Dec 1990
Decision
110d
Days
Class 1
Risk

About This 510(k) Submission

K904022 is an FDA 510(k) clearance for the NITRO BLUE TETRAZOLIUM REDUCTION, a Test, Leukocyte Alkaline Phosphatase (Class I — General Controls, product code GHD), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 18, 1990, 110 days after receiving the submission on August 30, 1990. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7660.

Submission Details

510(k) Number K904022 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1990
Decision Date December 18, 1990
Days to Decision 110 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code GHD — Test, Leukocyte Alkaline Phosphatase
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7660