# K962247: Hichem CK/Nac Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elan Pharma, Inc.
- Decided: Aug 15, 1996 after 65 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) BMD CK/NAC Reagent, product no. 816360: named in the summary without a submission number
- (no number) Sigma Diagnostics Creatine Kinase (CK) Reagent, procedure no. 47-UV: named in the summary without a submission number

## Indications for use
HiChem CK/NAC Reagent (product no. 70003) is intended for the quantitative determination of creatine kinase in serum and plasma. The principal diagnostic indications of elevated serum creatine kinase are diseases of the heart and skeletal muscle.

Source page: https://510kreport.com/device/K962247
Methodology: https://510kreport.com/methodology