Cleared Traditional

DIAGNON B12 57CO RIA KIT

K832717 · Diagnon Corp. · Chemistry
Dec 1983
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K832717 is an FDA 510(k) clearance for the DIAGNON B12 57CO RIA KIT, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Diagnon Corp. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983, 118 days after receiving the submission on August 12, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K832717 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1983
Decision Date December 08, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDD — Radioassay, Vitamin B12
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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