Cleared Traditional

K832531 - PHOTOMETER LP 300

K832531 is the FDA 510(k) clearance for PHOTOMETER LP 300 by Dr. Bruno Lange GmbH. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K832531 · Dr. Bruno Lange GmbH · Chemistry device
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Dec 1983
Decision
136d
Days
Class 1
Risk

K832531 is an FDA 510(k) clearance for the PHOTOMETER LP 300. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Dr. Bruno Lange GmbH (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983 after a review of 136 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 Dr. Bruno Lange GmbH devices

Submission Details

510(k) Number K832531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date December 12, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 88d · This submission: 136d
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 138
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