Cleared Traditional

MASTERCAP AM 5.0/MASTERCAP RM 5.0

K970420 · Pharmacia, Inc. · Chemistry
Jun 1997
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K970420 is an FDA 510(k) clearance for the MASTERCAP AM 5.0/MASTERCAP RM 5.0, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on June 30, 1997, 147 days after receiving the submission on February 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K970420 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1997
Decision Date June 30, 1997
Days to Decision 147 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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