Cleared Traditional

STAT DIFF STAIN

K791007 · Bioscientific · Hematology
Aug 1979
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K791007 is an FDA 510(k) clearance for the STAT DIFF STAIN, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979, 64 days after receiving the submission on May 31, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K791007 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1979
Decision Date August 03, 1979
Days to Decision 64 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