Cleared Traditional

K832712 - FOLATE RADIOASSAY KIT CA-1562-125

K832712 is the FDA 510(k) clearance for FOLATE RADIOASSAY KIT CA-1562-125 by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K832712 · Clinical Assays, Inc. · Chemistry device
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Oct 1983
Decision
53d
Days
Class 2
Risk

K832712 is an FDA 510(k) clearance for the FOLATE RADIOASSAY KIT CA-1562-125. Classified as Acid, Folic, Radioimmunoassay (product code CGN), 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 862.1295 - 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 K832712 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 CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 52
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K832712.
MILENIA FOLIC ACID
K921614 · Diagnostic Products Corp. · Jun 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689 · Microgenics Corp. · Jun 1992
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · Ciba Corning Diagnostics Corp. · Jul 1989
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
K812979 · Amersham Corp. · Nov 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · Bio-Rad · May 1981