# K960561: DSL Active Prolactin Elisa Model 10-4500

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Apr 26, 1996 after 77 days
- Product code: CFT (Radioimmunoassay, Prolactin (Lactogen))
- Device class: 1
- Regulation: 21 CFR 862.1625
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 3, 2009 · Not classified · Z-2047-2011: The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift 

Source page: https://510kreport.com/device/K960561
Methodology: https://510kreport.com/methodology