Cleared Traditional

K962836 - HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)

K962836 is an FDA 510(k) clearance for HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD), manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K962836 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
52d
Days
Class 2
Risk

K962836 is an FDA 510(k) clearance for the HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 Hemagen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K962836

510(k) Number K962836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date September 12, 1996
Days to Decision 52 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
53d faster than avg
Panel avg: 105d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K962836.
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · Teco Diagnostics · Nov 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
QUALITROL RF CONTROLS
K961545 · Consolidated Technologies, Inc. · Sep 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · Randox Laboratories, Ltd. · Jun 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996
RF IGM ELISA TEST SYSTEM
K961277 · Zeus Scientific, Inc. · May 1996