Cleaning Solution For Radiometer OSM2
by Fisher Scientific Co., LLC 510(k)
Active
510(k) K812623
Overview
The Cleaning Solution for Radiometer OSM2 is a chemical product used for the maintenance of electrode measurement systems. It is specifically formulated to clean components used in the analysis of blood gases, including Pco2, Po2, and blood pH.
This device is manufactured by Fisher Scientific Co., LLC and has received FDA 510(k) clearance. It is classified under the clinical chemistry medical specialty and is regulated under 21 CFR 862.1120.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812623 | Date2 Nov 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fisher Scientific Co., LLC
Questions
What is the primary purpose of the Cleaning Solution for Radiometer OSM2?
This solution is specifically formulated for the maintenance of electrode measurement systems. It is used to clean components involved in the analysis of blood gases, including Pco2, Po2, and blood pH.
Is this product regulated by the FDA?
Yes, the Cleaning Solution for Radiometer OSM2 has received FDA 510(k) clearance. It is classified under the clinical chemistry medical specialty and is regulated under 21 CFR 862.1120.
Who is the manufacturer of this cleaning solution?
This device is manufactured by Fisher Scientific Co., LLC, located in McHenry, Illinois.