Cleared Traditional

K960703 - RF-LATEX SEIKEN REAGENT SYSTEM

K960703 is an FDA 510(k) clearance for RF-LATEX SEIKEN REAGENT SYSTEM, manufactured by Globe Management Support, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K960703 · Globe Management Support, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
59d
Days
Class 2
Risk

K960703 is an FDA 510(k) clearance for the RF-LATEX SEIKEN REAGENT SYSTEM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Globe Management Support, Inc. (Chuo-Ku, Tokyo 103, JP). The FDA issued a Cleared decision on April 19, 1996 after a review of 59 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 Globe Management Support, Inc. devices

FDA 510(k) Submission Details - K960703

510(k) Number K960703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date April 19, 1996
Days to Decision 59 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
46d faster than avg
Panel avg: 105d · This submission: 59d
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 110
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K960703.
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
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · Hycor Biomedical, Inc. · Dec 1995
TEST, RHEUMATOID FACTOR
K955086 · Polymedco, Inc. · Dec 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 1995