Cleared Traditional

K852538 - LKB 4057 ULTROSPEC II E

K852538 is an FDA 510(k) clearance for LKB 4057 ULTROSPEC II E, manufactured by Lkb Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K852538 · Lkb Instruments, Inc. · Chemistry device
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Sep 1985
Decision
144d
Days
Class 1
Risk

K852538 is an FDA 510(k) clearance for the LKB 4057 ULTROSPEC II E. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on September 30, 1985 after a review of 144 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 Lkb Instruments, Inc. devices

FDA 510(k) Submission Details - K852538

510(k) Number K852538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date September 30, 1985
Days to Decision 144 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
56d slower than avg
Panel avg: 88d · This submission: 144d
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 165
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K852538.
RAICHEM/K.E
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K852411 · Dynatech Laboratories, Inc. · Sep 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · Em Diagnostic Systems, Inc. · Aug 1985
SC-360 SPECTROPHOTOMETER
K852047 · Pharmacia, Inc. · May 1985
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572 · Lkb Instruments, Inc. · May 1985