# K960551: DSL Active Human Growth Hormone Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Mar 6, 1996 after 27 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) Nichols Institute hGH IRMA: named in the summary without a submission number

## Indications for use
The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

Source page: https://510kreport.com/device/K960551
Methodology: https://510kreport.com/methodology