Cleared Traditional

K780885 - CORDIA R

K780885 is an FDA 510(k) clearance for CORDIA R, manufactured by Cordis Corp.. The device is a Class 2 Microbiology device with product code GOL cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K780885 · Cordis Corp. · Microbiology device
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Jan 1979
Decision
236d
Days
Class 2
Risk

K780885 is an FDA 510(k) clearance for the CORDIA R. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 236 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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 - K780885

510(k) Number K780885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1978
Decision Date January 17, 1979
Days to Decision 236 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
134d slower than avg
Panel avg: 102d · This submission: 236d
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 Microbiology 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 K780885.
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · Intl. Diagnostic Technology · Jan 1980
RUBAZYME
K790976 · Abbott Laboratories · Aug 1979
CORDIA T
K790212 · Cordis Corp. · Apr 1979
RUBA-NOST TEST KITS
K771796 · Behring Diagnostics, Inc. · Oct 1977
MEASLES-FA LABELLED (8-441 RF)
K770805 · Flow Laboratories, Inc. · May 1977
MEASLES-FA LABELED PRESERUM (8-441 RNF)
K770809 · Flow Laboratories, Inc. · May 1977