Cleared Traditional

K882608 - LAD MODEL 633 LUMINOMETER

K882608 is an FDA 510(k) clearance for LAD MODEL 633 LUMINOMETER, manufactured by Los Alamos Diagnostics. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K882608 · Los Alamos Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
66d
Days
Class 1
Risk

K882608 is an FDA 510(k) clearance for the LAD MODEL 633 LUMINOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Los Alamos Diagnostics (Los Alamos, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Los Alamos Diagnostics devices

FDA 510(k) Submission Details - K882608

510(k) Number K882608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date August 29, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K882608.
BEHRING TURBITIMER
K883646 · Behring Diagnostics, Inc. · Oct 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988
STAT FAX(TM)
K882938 · Awareness Technology, Inc. · Sep 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · Behring Diagnostics, Inc. · Aug 1988
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc. · Jun 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987