Cleared Traditional

K790212 - CORDIA T

K790212 is an FDA 510(k) clearance for CORDIA T, manufactured by Cordis Corp.. The device is a Class 2 Immunology device with product code GOL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K790212 · Cordis Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
72d
Days
Class 2
Risk

K790212 is an FDA 510(k) clearance for the CORDIA T. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1979 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3510 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K790212

510(k) Number K790212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1979
Decision Date April 12, 1979
Days to Decision 72 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 104d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GOL Device Classification - Class 2, Special Controls

Product Code GOL Antigen, Ha (including Ha Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - GOL Antigen, Ha (including Ha Control), Rubella

All 16
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K790212.
MACRO-VUE RUBELLA CARD TEST
K800797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · Intl. Diagnostic Technology · Jan 1980
RUBAZYME
K790976 · Abbott Laboratories · Aug 1979
CORDIA R
K780885 · Cordis Corp. · Jan 1979
RUBA-NOST TEST KITS
K771796 · Behring Diagnostics, Inc. · Oct 1977
MEASLES-FA LABELLED (8-441 RF)
K770805 · Flow Laboratories, Inc. · May 1977