Cleared Traditional

HEMATIL 18 (H-18)

K953643 · Texas Intl. Laboratories, Inc. · Hematology
Mar 1996
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K953643 is an FDA 510(k) clearance for the HEMATIL 18 (H-18), a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on March 22, 1996, 231 days after receiving the submission on August 4, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K953643 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1995
Decision Date March 22, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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