Cleared Traditional

K832717 - DIAGNON B12 57CO RIA KIT

K832717 is the FDA 510(k) clearance for DIAGNON B12 57CO RIA KIT by Diagnon Corp.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

K832717 is an FDA 510(k) clearance for the DIAGNON B12 57CO RIA KIT. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Diagnon Corp. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnon Corp. devices

Submission Details

510(k) Number K832717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date December 08, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K832717.
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127 · Micromedic Systems · Sep 1985
VITAMIN B12 57CO/FOLATE 125I -
K840462 · Corning Medical & Scientific · Jun 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247 · Bio-Rad · Oct 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726 · Diagnostic Products Corp. · Sep 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983