Cleared Traditional

ROBOCAP

K952025 · Pharmacia, Inc. · Chemistry
Jul 1995
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K952025 is an FDA 510(k) clearance for the ROBOCAP, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Pharmacia, Inc. (Dublin, US). The FDA issued a Cleared decision on July 26, 1995, 86 days after receiving the submission on May 1, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K952025 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1995
Decision Date July 26, 1995
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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