Device product
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
Z-1843-2016
Product summary
- Firm
- Medscience Inc
- Event
- Event 73664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,400 (Item 1000) & 380 (Item 1001)
- Official record key
device-enforcement:Z-1843-2016
Official wording
Reason: During an FDA inspection it was found that the products are marketed without a cleared 510k.
Code information: All lots
Distribution pattern: Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Derived failure modes
-
Unknown
During an FDA inspection it was found that the products are marketed without a cleared 510k.