Cleared Traditional

IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R

K930166 · Em Diagnostic Systems, Inc. · Chemistry
Apr 1993
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K930166 is an FDA 510(k) clearance for the IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on April 21, 1993, 98 days after receiving the submission on January 13, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K930166 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1993
Decision Date April 21, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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