Cleared Traditional

AUTOLET

K801815 · Ulster Scientific, Inc. · Hematology
Oct 1980
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K801815 is an FDA 510(k) clearance for the AUTOLET, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by Ulster Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 72 days after receiving the submission on July 30, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K801815 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1980
Decision Date October 10, 1980
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCA — Device, Bleeding Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6100