Cleared Traditional

K832710 - VITAMIN B12 RADIOASSAY KIT CA-1534

K832710 is the FDA 510(k) clearance for VITAMIN B12 RADIOASSAY KIT CA-1534 by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K832710 · Clinical Assays, Inc. · Chemistry device
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Oct 1983
Decision
53d
Days
Class 2
Risk

K832710 is an FDA 510(k) clearance for the VITAMIN B12 RADIOASSAY KIT CA-1534. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 53 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K832710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date October 04, 1983
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K832710.
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
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · Diagnostic Products Corp. · Feb 1983