Cleared Traditional

K974551 - SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY

K974551 is an FDA 510(k) clearance for SEALITE SCIENCES, manufactured by Sealite Sciences, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K974551 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
18d
Days
Class 2
Risk

K974551 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - the FDA in vitro diagnostics and chemistry 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 Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K974551

510(k) Number K974551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1997
Decision Date December 22, 1997
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 74
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