# K131738: Immunocap Specific Ige Control L, Immunocap Specific Ige Control M and Immunocap Specific Ige Control H

- Pathway: 510(k) (Special)
- Applicant: Phadia AB
- Decided: Jul 10, 2013 after 27 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- 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
- Nov 20, 2014 · Class II · Z-0947-2015: During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the samp

Source page: https://510kreport.com/device/K131738
Methodology: https://510kreport.com/methodology