Cleared Traditional

K854679 - PHOTIC-100 SPECTROPHOTOMETER

K854679 is the FDA 510(k) clearance for PHOTIC-100 SPECTROPHOTOMETER by Future Impex Corp.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854679 · Future Impex Corp. · Chemistry device
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Feb 1986
Decision
92d
Days
Class 1
Risk

K854679 is an FDA 510(k) clearance for the PHOTIC-100 SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on February 20, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Future Impex Corp. devices

Submission Details

510(k) Number K854679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date February 20, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 73
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K854679.
BEHRING RAPIMAT II
K861263 · Behring Diagnostics, Inc. · Oct 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · Terumo Medical Corp. · Dec 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · Em Diagnostic Systems, Inc. · Aug 1985
SC-360 SPECTROPHOTOMETER
K852047 · Pharmacia, Inc. · May 1985