Cleared Traditional

K840186 - SMI DIGITRON
(FDA 510(k) Clearance)

K840186 · Scientific Manufacturing Industries · Chemistry device

Apr 1984

Decision

78d

Days

Class 1

Risk

K840186 is an FDA 510(k) clearance for the SMI DIGITRON. This device is classified as a Micro Pipette (Class I - General Controls, product code JRC).

Submitted by Scientific Manufacturing Industries (Walker, US). The FDA issued a Cleared decision on April 5, 1984, 78 days after receiving the submission on January 18, 1984.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K840186 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1984
Decision Date	April 05, 1984
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—