# K961673: R&D Retic-PG Hematology Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Jul 15, 1996 after 75 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943336 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943336: Retic Control-H Hematology Control/Multiple, R&D Systems, Inc. (1994) Summary page 1.

## Indications for use
R&D Retic-PG™ is a tri-level, assayed hematology control designed to document and monitor reticulocyte values obtained from the CELL-DYN® 3500 System.

Source page: https://510kreport.com/device/K961673
Methodology: https://510kreport.com/methodology