Cleared Traditional

FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

K874054 · Fisher Scientific Co., LLC · Hematology
Oct 1987
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K874054 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS HEMATALL III LAS REAGENT, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on October 20, 1987, 15 days after receiving the submission on October 5, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K874054 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1987
Decision Date October 20, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540