Cleared Traditional

AQUALITE FSH (K943437) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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 87
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
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · Abbott Laboratories · Jun 1994
COBAS CORE FSH EIA
K930304 · Roche Diagnostic Systems, Inc. · Sep 1993
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
ENZYMUN TEST(R) FSH
K900763 · Boehringer Mannheim Corp. · Mar 1990
MILENIA(TM) FSH (MKFS1,5)
K895005 · Diagnostic Products Corp. · Oct 1989