# K022660: Biocheck Myoglobin Elisa, Model BC-1117

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Dec 19, 2002 after 132 days
- Product code: DRR (Amplifier And Signal Conditioner, Biopotential)
- Device class: 2
- Regulation: 21 CFR 870.2050
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BioCheck Myoglobin ELlSA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Source page: https://510kreport.com/device/K022660
Methodology: https://510kreport.com/methodology