Cleared Traditional

BLOOD DILUTION VIAL

K844042 · American Scientific Products · Hematology
Oct 1984
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K844042 is an FDA 510(k) clearance for the BLOOD DILUTION VIAL, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by American Scientific Products (Waukegan, US). The FDA issued a Cleared decision on October 23, 1984, 6 days after receiving the submission on October 17, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K844042 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1984
Decision Date October 23, 1984
Days to Decision 6 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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