# K021332: Wiener Lab. CK-Nac UV Unitest, Wiener Lab. CK-Nac UV AA, Wiener Lab. CK-Nac UV AA, Wiener Lab.Nac UV AA Liquida

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Jul 3, 2002 after 68 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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) DMA CK NAC test system (Cat. No 1380-200): named in the summary without a submission number
- (no number) RANDOX CK NAC-activated kit (Cat. No CK522): named in the summary without a submission number

## Indications for use
The "Wiener lab. CK-NAC UV" test system is a device intended to measure the activity of the enzyme creatine phosphokinase in plasma and serum with manual methodology and automated clinical chemistry analyzers. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K021332
Methodology: https://510kreport.com/methodology