Cleared Traditional

K852481 - UNI PAK 500 ANALYZER + CHEMISTRY REAGEN...

K852481 is the FDA 510(k) clearance for UNI PAK 500 ANALYZER + CHEMISTRY REAGEN... by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K852481 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1985
Decision
71d
Days
Class 1
Risk

K852481 is an FDA 510(k) clearance for the UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 71 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K852481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date August 21, 1985
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K852481.
MR 700 MICROPLATE READER 012-700-1000
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LKB 4057 ULTROSPEC II E
K852538 · Lkb Instruments, Inc. · Sep 1985
SC-360 SPECTROPHOTOMETER
K852047 · Pharmacia, Inc. · May 1985
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572 · Lkb Instruments, Inc. · May 1985
BEHRING VECTOR PHOTOMETER
K851098 · Behring Diagnostics, Inc. · Apr 1985