# K971353: DSL Active Non-Extraction Igf-I Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 12, 1997 after 31 days
- Product code: CFL (Radioimmunoassay, Human Growth Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1370
- 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) DSL 2800 Igf-I Irima: named in the summary without a submission number

## Indications for use
The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-I in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.

Source page: https://510kreport.com/device/K971353
Methodology: https://510kreport.com/methodology