Cleared Traditional

K852133 - REFLOTRON SYSTEM

K852133 is an FDA 510(k) clearance for REFLOTRON SYSTEM, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K852133 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
123d
Days
Class 1
Risk

K852133 is an FDA 510(k) clearance for the REFLOTRON SYSTEM. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K852133

510(k) Number K852133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1985
Decision Date September 16, 1985
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 144
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K852133.
ES 22
K854243 · Boehringer Mannheim Corp. · Nov 1985
KODAKEKTACHEM DTR MODULE
K854138 · Eastman Kodak Company · Nov 1985
HITACHI 704
K854025 · Boehringer Mannheim Corp. · Oct 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · Hi Chem, Inc. · Aug 1985
CLINALYZER MODEL VX-1000
K851638 · Alpkem Corp. · May 1985
ADD-1
K844114 · Abbott Laboratories · Nov 1984