# K950228: DSL Active Igfbp-3 Irma (DSL 6600)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Feb 22, 1995 after 42 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
- Aug 9, 2010 · Not classified · Z-2607-2010: The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are no

Source page: https://510kreport.com/device/K950228
Methodology: https://510kreport.com/methodology