Cleared Traditional

K810736 - LUMINESCENCE PHOTOMETER 100 SERIES

K810736 is an FDA 510(k) clearance for LUMINESCENCE PHOTOMETER 100 SERIES, manufactured by Sai Technology. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810736 · Sai Technology · Chemistry device
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Mar 1981
Decision
13d
Days
Class 1
Risk

K810736 is an FDA 510(k) clearance for the LUMINESCENCE PHOTOMETER 100 SERIES. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Sai Technology (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 13 days - a notably fast clearance cycle.

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: 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 Sai Technology devices

FDA 510(k) Submission Details - K810736

510(k) Number K810736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1981
Decision Date March 31, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K810736.
ACCUDEX
K811680 · Biodynamics Corp. · Jul 1981
QUICK-CHEM COLORIMETER
K811806 · The Dow Chemical Co. · Jul 1981
GILUCOCHEK REFLECTANCE METER
K810665 · Lifescan, Inc. · Apr 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · Beckman Instruments, Inc. · Mar 1981
BCA 1000
K810105 · Biodynamics Corp. · Feb 1981
LKB-WALLACE 1250 LUMINOMETER
K803131 · Lkb Instruments, Inc. · Jan 1981