Mast Cla Allergy System
by Mast Immunosystems 3 variants
510(k) K910292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910292 | Date5 Apr 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DHB
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5750
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mast Cla Allergy System is a Test, Radioallergosorbent (Rast) Immunological device. It is classified as a class 2 device. The system is used in the field of Immunology.
The device is supplied by Mast Immunosystems and has been found to be Substantially Equivalent. It has an FDA 510K authorization, with a clearance type of Traditional and a regulation number of 866.5750. The device has a product code of DHB and is associated with multiple fei numbers and registration numbers.
Other devices from Mast Immunosystems
Questions
AI-generated answers, 1 Oct 2026
What is the Mast Cla Allergy System used for?
The Mast Cla Allergy System is used in the field of Immunology as a Test, Radioallergosorbent (Rast) Immunological device to detect allergies.
What type of device is the Mast Cla Allergy System?
The Mast Cla Allergy System is classified as a class 2 device and has a product code of DHB.
Is the Mast Cla Allergy System authorized by the FDA?
Yes, the Mast Cla Allergy System has an FDA 510K authorization with a clearance type of Traditional and a regulation number of 866.5750.