Cleared Traditional

K875098 - CIBA CORNING MODEL 644

K875098 is an FDA 510(k) clearance for CIBA CORNING MODEL 644, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JXR cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K875098 · Ciba Corning Diagnostics Corp. · Chemistry device
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Mar 1988
Decision
84d
Days
Class 1
Risk

K875098 is an FDA 510(k) clearance for the CIBA CORNING MODEL 644. Classified as Atomic Absorption Spectrophotometer, General Use (product code JXR), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2850 - 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K875098

510(k) Number K875098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1987
Decision Date March 03, 1988
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

JXR Device Classification - Class 1, General Controls

Product Code JXR Atomic Absorption Spectrophotometer, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2850
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 - JXR Atomic Absorption Spectrophotometer, General Use

All 28
Devices cleared under the same product code (JXR) and FDA review panel - the closest regulatory comparables to K875098.
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
K900828 · The Perkin-Elmer Corp. · Apr 1990
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT
K842752 · The Perkin-Elmer Corp. · Aug 1984
ICP/6500 INDUCTIVELY-COUPLED PLASMA-
K842496 · The Perkin-Elmer Corp. · Aug 1984
INDUCTIVELY-COUPLED PLASMA SPECTROMETER
K830799 · The Perkin-Elmer Corp. · Apr 1983
MODEL 3030 ATOMIC ABSORPTION SPECTRO-
K820320 · The Perkin-Elmer Corp. · Mar 1982
ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB
K810536 · The Perkin-Elmer Corp. · Mar 1981