Cleared Traditional

K921005 - AUTOLOADER
(FDA 510(k) Clearance)

K921005 · Innovative Medical Systems, Inc. · Hematology

Apr 1992

Decision

57d

Days

Class 1

Risk

K921005 is an FDA 510(k) clearance for the AUTOLOADER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW).

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on April 29, 1992, 57 days after receiving the submission on March 3, 1992.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number	K921005 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1992
Decision Date	April 29, 1992
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement