Cleared Traditional

K871550 - PFI-20 POLARIZING FLUORIMETER

K871550 is an FDA 510(k) clearance for PFI-20 POLARIZING FLUORIMETER, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K871550 · The Perkin-Elmer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
70d
Days
Class 1
Risk

K871550 is an FDA 510(k) clearance for the PFI-20 POLARIZING FLUORIMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on July 1, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K871550

510(k) Number K871550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1987
Decision Date July 01, 1987
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 29
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K871550.
DELFIA PLATE FLUOROMETER 1232
K895240 · Pharmacia, Inc. · Oct 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · Pb Diagnostic Systems, Inc. · Aug 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · Lkb Instruments, Inc. · May 1985
FLUOROMETER, GENERAL USE
K830624 · Abbott Diagnostics · Apr 1983