Cleared Traditional

K843751 - CORDIA HS ANTIBODY TYPING REAGENTS

K843751 is an FDA 510(k) clearance for CORDIA HS ANTIBODY TYPING REAGENTS, manufactured by Cordis Corp.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K843751 · Cordis Corp. · Microbiology device
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Apr 1985
Decision
211d
Days
Class 2
Risk

K843751 is an FDA 510(k) clearance for the CORDIA HS ANTIBODY TYPING REAGENTS. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on April 24, 1985 after a review of 211 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K843751

510(k) Number K843751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date April 24, 1985
Days to Decision 211 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 102d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQN Device Classification - Class 2, Special Controls

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 Microbiology devices follow this clearance model.

Regulatory Peers - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 18
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K843751.
ORTHO HSV ANTIGEN ELISA TEST
K854488 · Ortho Diagnostic Systems, Inc. · Feb 1986
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · Bartels Immunodiagnostic Supplies, Inc. · Nov 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · Hillcrest Biologicals · May 1985
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · Syva Co. · Jun 1984
CORDIA HS
K832875 · Cordis Corp. · Nov 1983