# K993321: R&D HGB/GLC Whole Blood Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Nov 12, 1999 after 39 days
- Product code: GGM (Control, Hemoglobin)
- 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: 2 generations back to K934641 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961195: Chem-Chex Stat, Streck Laboratories, Inc. (1996) Summary page 1.

## Most influential descendants
- K034048: R&D Glu-Line Hematology Control (2004), 0 descendants of its own

## Indications for use
R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.

Source page: https://510kreport.com/device/K993321
Methodology: https://510kreport.com/methodology