Cleared Traditional

MINI SAMPLER PROCESSOR

K970616 · Cavro Scientific Instruments, Inc. · Chemistry

Apr 1997

Decision

62d

Days

Class 1

Risk

About This 510(k) Submission

K970616 is an FDA 510(k) clearance for the MINI SAMPLER PROCESSOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Cavro Scientific Instruments, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 21, 1997, 62 days after receiving the submission on February 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number	K970616 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 1997
Decision Date	April 21, 1997
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF