Cleared Traditional

K841043 - BEHRING ELISA PROCESSOR M

K841043 is an FDA 510(k) clearance for BEHRING ELISA PROCESSOR M, manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K841043 · Behring Diagnostics, Inc. · Chemistry device
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Jul 1984
Decision
116d
Days
Class 1
Risk

K841043 is an FDA 510(k) clearance for the BEHRING ELISA PROCESSOR M. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K841043

510(k) Number K841043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date July 06, 1984
Days to Decision 116 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
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K841043.
AUTOLOADER II
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FIAX 420 DILUTOR
K843621 · Intl. Diagnostic Technology · Sep 1984
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · Syva Co. · Jul 1984
HIGH SPEED DISPENSER
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ACCUFLEX
K834590 · Micromedic Systems · Mar 1984
MICROLAB M DILUTER/DISPENSER
K833959 · Syva Co. · Jan 1984