Cleared Traditional

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT

K903995 · Sigma Chemical Co. · Pathology
Dec 1990
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K903995 is an FDA 510(k) clearance for the NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT, 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 13, 1990, 106 days after receiving the submission on August 29, 1990. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7660.

Submission Details

510(k) Number K903995 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1990
Decision Date December 13, 1990
Days to Decision 106 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