# K130236: Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Mar 15, 2013 after 44 days
- Product code: JJS (Controls For Blood-Gases, (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952725 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760, Radiometer America, Inc. (1998) Summary page 2.

## Indications for use
For In Vitro Diagnostic Use. This Range± QUALICHECK solution i an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pH, PCO 2, PO2, ctHb, SO2 , FO2Hb, FCOHb, FMetI-b, FHbF-, cKt, cNa', cCa2 1,cCF-, cGlu, cLac, ctBil

Source page: https://510kreport.com/device/K130236
Methodology: https://510kreport.com/methodology