Cleared Traditional

IRON TEST

K881202 · Sclavo, Inc. · Chemistry
Apr 1988
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K881202 is an FDA 510(k) clearance for the IRON TEST, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on April 28, 1988, 38 days after receiving the submission on March 21, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K881202 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date April 28, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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