Cleared Traditional

HEMASTAIN FIXATIVE

K760485 · Geometric Data, Div. Smithkline Corp. · Hematology
Aug 1976
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K760485 is an FDA 510(k) clearance for the HEMASTAIN FIXATIVE, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976, 10 days after receiving the submission on August 20, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K760485 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1976
Decision Date August 30, 1976
Days to Decision 10 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQC — Stains, Hematology
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850