# K984384: 6.8/7.3 Buffer Pack-Model A473-496, Wash Solution Pack-Model A73-497

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Bioanalysis Corp.
- Decided: Dec 23, 1998 after 15 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chiron Diagnostics 6.8 / 7.3 Buffer Pack: named in the summary without a submission number
- (no number) Chiron Diagnostics Wash Solution: named in the summary without a submission number

## Indications for use
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas tests. ALKO manufactures the calibration reagents for the analyzer’s analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics. The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers sample flow path. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K984384
Methodology: https://510kreport.com/methodology