Cleared Traditional

UNILET LANCET

K842517 · Ulster Scientific, Inc. · General Hospital
Sep 1984
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K842517 is an FDA 510(k) clearance for the UNILET LANCET, a Chair, Blood Donor (Class I — General Controls, product code FML), submitted by Ulster Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984, 72 days after receiving the submission on July 10, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6140.

Submission Details

510(k) Number K842517 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1984
Decision Date September 20, 1984
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FML — Chair, Blood Donor
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6140