# K896294: DSL I-PTH (DSL #8000)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Nov 21, 1989 after 21 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020945: Axsym Intact PTH, Model 2G06 (2002), 0 descendants of its own

## Recalls of this device
- Apr 22, 2010 · Not classified · Z-0585-2011: The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected 

Source page: https://510kreport.com/device/K896294
Methodology: https://510kreport.com/methodology