Cleared Traditional

K833017 - SERUM IRON & TIBC#65084 & 65085
(FDA 510(k) Clearance)

K833017 · Emd Chemicals, Inc. · Chemistry

Nov 1983

Decision

58d

Days

Class 1

Risk

K833017 is an FDA 510(k) clearance for the SERUM IRON & TIBC#65084 & 65085. This device is classified as a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY).

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 58 days after receiving the submission on September 6, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number	K833017 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1983
Decision Date	November 03, 1983
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—