Cleared Traditional

LABTRONIX PLATELET COUNTER(L/O/C.)

K811084 · Labtronix Corp. · Radiology
Jul 1981
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K811084 is an FDA 510(k) clearance for the LABTRONIX PLATELET COUNTER(L/O/C.), a Platelet Counting, Manual (Class I — General Controls, product code GLG), submitted by Labtronix Corp. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981, 93 days after receiving the submission on April 21, 1981. This device falls under the Radiology review panel. Regulated under 21 CFR 864.6160.

Submission Details

510(k) Number K811084 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 1981
Decision Date July 23, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code GLG — Platelet Counting, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.6160