Cleared Traditional

FERROFAST

K863109 · J. D. Assoc. · Chemistry
Nov 1986
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K863109 is an FDA 510(k) clearance for the FERROFAST, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 24, 1986, 103 days after receiving the submission on August 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K863109 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1986
Decision Date November 24, 1986
Days to Decision 103 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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