Cleared Traditional

K942364 - HITACHI 914 ANALYZER

K942364 is an FDA 510(k) clearance for HITACHI 914 ANALYZER, 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 140-day FDA review.

K942364 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
140d
Days
Class 1
Risk

K942364 is an FDA 510(k) clearance for the HITACHI 914 ANALYZER. 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 October 4, 1994 after a review of 140 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 - K942364

510(k) Number K942364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date October 04, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
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 K942364.
MICROPLATE PROCESSOR 3000
K945135 · Organon Teknika Corp. · Mar 1995
PROCHEM CHEMISTRY ANALYZER
K944028 · Prisma Systems · Nov 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1994
AURAFLEX SYSTEMS
K942443 · Organon Teknika Corp. · Aug 1994
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
K940810 · Ciba Corning Diagnostics Corp. · May 1994
SIGMA WASH CONCENTRATE SOLUTION
K933703 · Sigma Chemical Co. · Dec 1993