# K913687: Chem-Chex

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Sep 19, 1991 after 31 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K102700: Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials (2010), 0 descendants of its own

## Recalls of this device
- Oct 6, 2010 · Not classified · Z-0439-2011: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
- Oct 6, 2010 · Not classified · Z-0443-2011: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
- Oct 6, 2010 · Not classified · Z-0442-2011: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
- Oct 6, 2010 · Not classified · Z-0440-2011: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
- Oct 6, 2010 · Not classified · Z-0441-2011: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.

Source page: https://510kreport.com/device/K913687
Methodology: https://510kreport.com/methodology