Cleared Traditional

K943691 - IMX FOLATE

K943691 is an FDA 510(k) clearance for IMX FOLATE, manufactured by Abbott Mfg., Inc.. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K943691 · Abbott Mfg., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
237d
Days
Class 2
Risk

K943691 is an FDA 510(k) clearance for the IMX FOLATE. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Abbott Mfg., Inc. (Abbott Park, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 237 days - an extended review 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: 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 Abbott Mfg., Inc. devices

FDA 510(k) Submission Details - K943691

510(k) Number K943691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date March 23, 1995
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGN Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K943691.
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · Beckman Coulter, Inc. · Jan 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · Bayer Corp. · Jan 1996
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · Microgenics Corp. · Jun 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · Bio-Rad · Feb 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · Microgenics Corp. · Jan 1995
CIBA CORNING ACS FOLATE ASSAY
K943297 · Ciba Corning Diagnostics Corp. · Dec 1994