# K891235: Primus Model CLC 330

- Pathway: 510(k) (Traditional)
- Applicant: Primus, Inc.
- Decided: Jun 16, 1989 after 101 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K112015: Premier HB9210 HBA1C Analyzer (2011), 0 descendants of its own
- K062658: Primus A1CARE Assay (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K891235
Methodology: https://510kreport.com/methodology