Cleared Traditional

K943437 - AQUALITE FSH

K943437 is an FDA 510(k) clearance for AQUALITE FSH, manufactured by Sealite Sciences, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K943437 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
163d
Days
Class 1
Risk

K943437 is an FDA 510(k) clearance for the AQUALITE FSH. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Sealite Sciences, Inc. (Bogart, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 163 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 - K943437

510(k) Number K943437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date December 28, 1994
Days to Decision 163 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
75d slower than avg
Panel avg: 88d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 68
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K943437.
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996
AMERLITE FSH ASSAY
K952285 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221 · Dupont Medical Products · Jul 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · Abbott Laboratories · Jun 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005 · Bio-Rad Laboratories, Inc. · Mar 1994