# K961918: Multi-Test II

- Pathway: 510(k) (Traditional)
- Applicant: Lincoln Diagnostics, Inc.
- Decided: Aug 7, 1996 after 82 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K182582: Oryum and Ovem Epidermal Deri Prick Test Applicator (2019), 1 descendant of its own
- K250983: Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (2026), 0 descendants of its own
- K162917: Allerhope Allergy Skin Tester (2017), 0 descendants of its own

## Indications for use
The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.

Source page: https://510kreport.com/device/K961918
Methodology: https://510kreport.com/methodology