Cleared Traditional

K884708 - FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOA...

K884708 is the FDA 510(k) clearance for FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOA... by Cyberfluor, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K884708 · Cyberfluor, Inc. · Chemistry device
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Jan 1989
Decision
69d
Days
Class 1
Risk

K884708 is an FDA 510(k) clearance for the FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on January 17, 1989 after a review of 69 days - a notably fast clearance 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: 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 Cyberfluor, Inc. devices

Submission Details

510(k) Number K884708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1988
Decision Date January 17, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 45
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K884708.
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · Hybritech, Inc. · Sep 1989
COAT-A-COUNT (TM) FSH IRMA
K893976 · Diagnostic Products Corp. · Aug 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · Ciba Corning Diagnostics Corp. · Dec 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
PHASE II FSH KIT
K883279 · Vitek Systems, Inc. · Sep 1988