Cleared Traditional

K854762 - HEPANORM CALIBRATION PLASMA SET

K854762 is the FDA 510(k) clearance for HEPANORM CALIBRATION PLASMA SET by American Bioproducts Co.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K854762 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
96d
Days
Class 2
Risk

K854762 is an FDA 510(k) clearance for the HEPANORM CALIBRATION PLASMA SET. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - the FDA hematology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K854762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date March 03, 1986
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 Hematology devices follow this clearance model.

Regulatory Peers - KFF Assay, Heparin

All 28
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K854762.
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · Warner-Lambert Co. · May 1985
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
HEPARIN CALIBRATOR ACA
K843202 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984