Cleared Traditional

PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES (K844894) - FDA 510(k) Clearance

Class I Chemistry device.

K844894 · Slt Labinstruments, Inc. · Chemistry device
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Jun 1985
Decision
190d
Days
Class 1
Risk

K844894 is an FDA 510(k) clearance for the PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Slt Labinstruments, Inc. (Walker, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 190 days - an extended review 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: 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 Slt Labinstruments, Inc. devices

Submission Details

510(k) Number K844894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 25, 1985
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
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 32
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K844894.
ADX(TM) ANALYZER
K864566 · Abbott Laboratories · Feb 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · Em Diagnostic Systems, Inc. · Aug 1985
UROTRON RL9
K850348 · Boehringer Mannheim Corp. · Mar 1985
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · Helena Laboratories · Aug 1982