Cleared Traditional

KVM ISOTONIC DILUENT

K883990 · Kvm Technologies, Inc. · Hematology
Oct 1988
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K883990 is an FDA 510(k) clearance for the KVM ISOTONIC DILUENT, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Kvm Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on October 12, 1988, 22 days after receiving the submission on September 20, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K883990 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1988
Decision Date October 12, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200

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