Cleared Traditional

K913664 - ROSYS MODELS 100 AND 200
(FDA 510(k) Clearance)

K913664 · Packard Instrument Co., Inc. · Chemistry

Aug 1991

Decision

14d

Days

Class 1

Risk

K913664 is an FDA 510(k) clearance for the ROSYS MODELS 100 AND 200, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on August 30, 1991, 14 days after receiving the submission on August 16, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number	K913664 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1991
Decision Date	August 30, 1991
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement