Cleared Traditional

K791216 - CENTRIA VITAMIN B12 FOLATE RADIO SET

K791216 is an FDA 510(k) clearance for CENTRIA VITAMIN B12 FOLATE RADIO SET, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K791216 · Ventrex Laboratories, Inc. · Chemistry device
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Nov 1979
Decision
134d
Days
Class 2
Risk

K791216 is an FDA 510(k) clearance for the CENTRIA VITAMIN B12 FOLATE RADIO SET. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 134 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 Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K791216

510(k) Number K791216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1979
Decision Date November 13, 1979
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K791216.
'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
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · New England Nuclear · Nov 1979
AUTO PAK VITAMIN B-12
K790347 · Micromedic Systems · Sep 1979
VITAMIN B12 RADIOASSAY
K780799 · Amersham Corp. · Jun 1978