Cleared Traditional

K874621 - FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201

K874621 is an FDA 510(k) clearance for FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: ..., manufactured by Cyberfluor, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K874621 · Cyberfluor, Inc. · Chemistry device
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Jan 1988
Decision
62d
Days
Class 1
Risk

K874621 is an FDA 510(k) clearance for the FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on January 11, 1988 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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

FDA 510(k) Submission Details - K874621

510(k) Number K874621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1987
Decision Date January 11, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 65
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K874621.
PRL-QUANT
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K880218 · Binax, Inc. · Mar 1988
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · Medix Biotech, Inc. · Oct 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · Serono Diagnostics, Inc. · Sep 1987
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
K872862 · Serono Diagnostics, Inc. · Sep 1987