Cleared Traditional

ACE IRON REAGENT

K944911 · Schiapparelli Biosystems, Inc. · Chemistry
Feb 1995
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K944911 is an FDA 510(k) clearance for the ACE IRON REAGENT, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on February 10, 1995, 128 days after receiving the submission on October 5, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K944911 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1994
Decision Date February 10, 1995
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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