Cleared Traditional

CELL-DYN ISOTONIC DILUENT

K881130 · Abbott Diagnostics · Hematology
Mar 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K881130 is an FDA 510(k) clearance for the CELL-DYN ISOTONIC DILUENT, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on March 31, 1988, 15 days after receiving the submission on March 16, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K881130 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1988
Decision Date March 31, 1988
Days to Decision 15 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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