Cleared Traditional

K781012 - RIA TEST KIT SYS. DAMON KIQUISOL FREE

K781012 is an FDA 510(k) clearance for RIA TEST KIT SYS. DAMON KIQUISOL FREE, manufactured by Damon Corp.. The device is a Class 2 Hematology device with product code CEC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K781012 · Damon Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1978
Decision
41d
Days
Class 2
Risk

K781012 is an FDA 510(k) clearance for the RIA TEST KIT SYS. DAMON KIQUISOL FREE. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1695 - the FDA hematology 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 Damon Corp. devices

FDA 510(k) Submission Details - K781012

510(k) Number K781012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1978
Decision Date July 27, 1978
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 Hematology devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 80
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K781012.
FREE T4 RIA TEST SET
K813465 · Ventrex Laboratories, Inc. · Dec 1981
CODE IM 2050 AMERLEX FREE T4 RIA KIT
K810231 · Amersham Corp. · Feb 1981
RIA DIAG. TEST KIT FOR INDEXING THYROX.
K781560 · Nuclear Diagnostics, Inc. · Oct 1978
IMMO PHASE FT4 ASSAY
K772194 · Corning Medical & Scientific · Jan 1978
TRIOBEAD-125 DIAGNOSTIC KIT
K771236 · Abbott Laboratories · Aug 1977