Cleared Traditional

K923410 - FIAGEN PROGESTERONE

K923410 is an FDA 510(k) clearance for FIAGEN PROGESTERONE, manufactured by Cyberfluor, Inc.. The device is a Class 1 Hematology device with product code JLS cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K923410 · Cyberfluor, Inc. · Hematology device
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Dec 1992
Decision
146d
Days
Class 1
Risk

K923410 is an FDA 510(k) clearance for the FIAGEN PROGESTERONE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on December 3, 1992 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1620 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cyberfluor, Inc. devices

FDA 510(k) Submission Details - K923410

510(k) Number K923410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date December 03, 1992
Days to Decision 146 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 113d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K923410.
AIA-PACK(R) PROG ASSAY
K933269 · Tosoh Medics, Inc. · Oct 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
K933635 · Baxter Diagnostics, Inc. · Oct 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · Ciba Corning Diagnostics Corp. · Aug 1993
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
K914462 · Serono-Baker Diagnostics, Inc. · Oct 1991
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991