# K980757: Ilab 600 Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 21, 1998 after 53 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932467 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932467: Ilab 900/1800 Clinical Chemistry System, Instrumentation Laboratory CO (1993) Summary page 2.
- K943595: Serum/Urine Appli Ilab (TM) Clinical Chemistry System, Instrumentation Laboratory CO (1994) Summary page 2.
- K943366: IL Test Acid Phosphatase, Instrumentation Laboratory CO (1996) Summary page 2.
- K952646: IL Test CK-MB, Instrumentation Laboratory CO (1995) Summary page 2.
- K943367: IL Test Cholinesterase, Instrumentation Laboratory CO (1996) Summary page 2.
- K952647: IL Test Lipase, Instrumentation Laboratory CO (1995) Summary page 2.

## Indications for use
The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

Source page: https://510kreport.com/device/K980757
Methodology: https://510kreport.com/methodology