Cleared Traditional

K791216 - CENTRIA VITAMIN B12 FOLATE RADIO SET

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

K791216 · Ventrex Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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
AUTO PAK VITAMIN B-12
K790347 · Micromedic Systems · Sep 1979
VITAMIN B12 RADIOASSAY
K780799 · Amersham Corp. · Jun 1978
QUANTA-MATE VITAMIN B-12/FOLATE RA
K771047 · Bio-Rad · Jun 1977