Cleared Traditional

K943149 - ACCESS RED BLOOD CELL FOLATE ASSAY

K943149 is the FDA 510(k) clearance for ACCESS RED BLOOD CELL FOLATE ASSAY by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code CGN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K943149 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
57d
Days
Class 2
Risk

K943149 is an FDA 510(k) clearance for the ACCESS RED BLOOD CELL FOLATE ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1295 - the FDA immunology device 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K943149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date August 26, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 104d · This submission: 57d
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 Immunology devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K943149.
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · Microgenics Corp. · Jan 1995
CIBA CORNING ACS FOLATE ASSAY
K943297 · Ciba Corning Diagnostics Corp. · Dec 1994
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994
QUANTAPHASE II B12/FOLATE
K935286 · Bio-Rad · Feb 1994
VISTA FOLATE ASSAY
K934121 · Syva Co. · Oct 1993
ACCESS FOLATE ASSAY
K932887 · Beckman Coulter, Inc. · Oct 1993