Cleared Traditional

LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT (K922976) - FDA 510(k) Clearance

Class I Chemistry device.

K922976 · Eg&G Berthold Analytical Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
171d
Days
Class 1
Risk

K922976 is an FDA 510(k) clearance for the LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Eg&G Berthold Analytical Instruments, Inc. (Nashua, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 171 days - an extended review cycle.

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 Eg&G Berthold Analytical Instruments, Inc. devices

Submission Details

510(k) Number K922976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date November 16, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 88d · This submission: 171d
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 32
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K922976.
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · Instrumentation Laboratory CO · Nov 1994
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · Boehringer Mannheim Corp. · Nov 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · Instrumentation Laboratory CO · Nov 1993
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · Roche Diagnostic Systems, Inc. · Jul 1992
AMERLITE PROCESSING CENTER
K915680 · Eastman Kodak Company · Mar 1992
MICROTAK PLUS
K913840 · Syva Co. · Sep 1991