# K951707: DSL Active Ifgbp-3 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 10, 1995 after 27 days
- Product code: CFL (Radioimmunoassay, Human Growth Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1370
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 30, 2011 · Not classified · Z-2184-2011: The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).

Source page: https://510kreport.com/device/K951707
Methodology: https://510kreport.com/methodology