Cleared Traditional

K813183 - NO-BOIL VITABIN B12 5760 FOLATE 125I

K813183 is the FDA 510(k) clearance for NO-BOIL VITABIN B12 5760 FOLATE 125I by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K813183 · Corning Medical & Scientific · Chemistry device
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Mar 1982
Decision
109d
Days
Class 2
Risk

K813183 is an FDA 510(k) clearance for the NO-BOIL VITABIN B12 5760 FOLATE 125I. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982 after a review of 109 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K813183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1981
Decision Date March 05, 1982
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
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 55
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K813183.
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
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · Diagnostic Products Corp. · Feb 1983
'NO-BOIL' VITAMIN B12 KIT
K810002 · Diagnostic Products Corp. · Jan 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · Corning Medical & Scientific · Jan 1981
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · Calbiochem-Behring Corp. · Feb 1980