Cleared Traditional

K792175 - RIANEN

K792175 is the FDA 510(k) clearance for RIANEN by New England Nuclear. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K792175 · New England Nuclear · Chemistry device
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Nov 1979
Decision
15d
Days
Class 2
Risk

K792175 is an FDA 510(k) clearance for the RIANEN, VITAMIN B12 ASSAY SYSTEM. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New England Nuclear devices

Submission Details

510(k) Number K792175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1979
Decision Date November 13, 1979
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K792175.
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · Corning Medical & Scientific · Jan 1981
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · Calbiochem-Behring Corp. · Feb 1980
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · Ventrex Laboratories, Inc. · Nov 1979
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