Cleared Traditional

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT

K896092 · Sigma Chemical Co. · Hematology
Nov 1989
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K896092 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE, LEUKOCYTE, 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 November 9, 1989, 21 days after receiving the submission on October 19, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7660.

Submission Details

510(k) Number K896092 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1989
Decision Date November 09, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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