Elisa-Doxa SCL-70
by Advanced Biological Products, Inc.
510(k) K924949
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924949 | Date19 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Elisa-Doxa Scl-70 is an extractable antinuclear antibody, antigen and control device. It is designed for use in immunology applications to assist in the detection of specific antibodies.
This device is regulated under FDA 510(k) clearance K924949. It is classified as a class 2 medical device under regulation number 866.5100.
Other devices from Advanced Biological Products, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the primary purpose of the Elisa-Doxa Scl-70?
The Elisa-Doxa Scl-70 is designed for use in immunology applications to assist in the detection of specific antibodies. It functions as an extractable antinuclear antibody, antigen and control device.
What is the regulatory classification of this device?
This device is classified as a class 2 medical device under regulation number 866.5100. It has received FDA 510(k) clearance under the number K924949.
Which medical specialty is this device intended for?
The Elisa-Doxa Scl-70 is intended for use within the field of immunology. This is reflected in its classification under the immunology advisory committee.