Cleared Traditional

K761234 - BEHRING LASER NEPHELOMETER

K761234 is the FDA 510(k) clearance for BEHRING LASER NEPHELOMETER by Behring Diagnostics, Inc.. It is a Class 1 Immunology device (product code JZW) cleared through the Traditional 510(k) pathway .

K761234 · Behring Diagnostics, Inc. · Immunology device
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Jun 1990
Decision
-
Days
Class 1
Risk

K761234 is an FDA 510(k) clearance for the BEHRING LASER NEPHELOMETER. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on June 7, 1990.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4540 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K761234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1990
Decision Date June 07, 1990
Days to Decision -
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
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 - JZW Nephelometer

All 9
Devices cleared under the same product code (JZW) and FDA review panel - the closest regulatory comparables to K761234.
BN PROSPEC SYSTEM
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DISC 120 TRANSPORTER
K801391 · Travenol Laboratories, S.A. · Jul 1980
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · Sherwood Medical Industries · Nov 1979