Cleared Traditional

K861617 - THE PARTNER SPECTROPHOTOMETER

K861617 is the FDA 510(k) clearance for THE PARTNER SPECTROPHOTOMETER by Pharmacia, Inc.. It is a Class 1 Immunology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K861617 · Pharmacia, Inc. · Immunology device
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May 1986
Decision
20d
Days
Class 1
Risk

K861617 is an FDA 510(k) clearance for the THE PARTNER SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on May 19, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2300 - the FDA immunology 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: 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K861617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 19, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K861617.
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
BEHRING RAPIMAT II
K861263 · Behring Diagnostics, Inc. · Oct 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · Lkb Instruments, Inc. · Apr 1986
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · Terumo Medical Corp. · Dec 1985