Cleared Traditional

K943188 - SEALITE SCIENCE, INC. AQUALITE(R) LH

K943188 is an FDA 510(k) clearance for SEALITE SCIENCE, manufactured by Sealite Sciences, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K943188 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
107d
Days
Class 1
Risk

K943188 is an FDA 510(k) clearance for the SEALITE SCIENCE, INC. AQUALITE(R) LH. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Sealite Sciences, Inc. (Bogart, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K943188

510(k) Number K943188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date October 20, 1994
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 99
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K943188.
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
CHEMILUMINESCENCE LH
K935319 · Nichols Institute Diagnostics · Apr 1995
PRO-STEP LH OVULATION PREDICTION TEST
K943252 · Disease Detection International, Inc. · Oct 1994
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K943996 · Dupont Medical Products · Oct 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994