Cleared Traditional

RDW AND MPV INDICES ON HEMAT 12

K900684 · Texas Intl. Laboratories, Inc. · Hematology
Apr 1990
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K900684 is an FDA 510(k) clearance for the RDW AND MPV INDICES ON HEMAT 12, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Texas Intl. Laboratories, Inc. (Needham, US). The FDA issued a Cleared decision on April 16, 1990, 63 days after receiving the submission on February 12, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K900684 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1990
Decision Date April 16, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220