# K931756: Quantikine (TM) Erythropoietin Human Serum Controls

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Apr 21, 1994 after 378 days
- Product code: GGT (Assay, Erythropoietin)
- Device class: 2
- Regulation: 21 CFR 864.7250
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 14, 2022 · Class III · Z-1390-2022: The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by t

Source page: https://510kreport.com/device/K931756
Methodology: https://510kreport.com/methodology