# K003098: Access Ultrasensitive HGH Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 20, 2000 after 48 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K040181: Access Dhea-S Reagent Assay (2004), 1 descendant of its own
- K111762: ST Aia-Pack Dhea-S Calibrator Set (2011), 0 descendants of its own
- K061282: Access Ultrasensitive HGH Calibrator, Model 33585 (2006), 0 descendants of its own
- K042651: Free T3 Calibrators on the Access Immunoassay Systems (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K003098
Methodology: https://510kreport.com/methodology