Microsomal EIA Test Kit
by Immunoprobe, Inc. 510(k) 2 variants
Active
510(k) K951364
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951364 | Date20 Nov 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JNL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5870
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Microsomal EIA Test Kit is an immunochemical device for detecting thyroglobulin autoantibody. It is classified as a Class II medical device under regulation number 866.5870.
The device received FDA 510(k) clearance (K951364) on November 20, 1995, and is substantially equivalent to a predicate device. It is manufactured by Immunoprobe, Inc. and falls under the immunology medical specialty.
Other devices from Immunoprobe, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Microsomal EIA Test Kit used for?
The Microsomal EIA Test Kit is an immunochemical device designed to detect thyroglobulin autoantibody in patient samples, aiding in the assessment of autoimmune thyroid conditions.
How is the Microsomal EIA Test Kit supplied and is it sterile or single-use?
The device data does not specify the kit's format, sterility, or single-use/reuse status; these details must be obtained from the manufacturer's labeling or instructions for use.
What regulatory clearance does the Microsomal EIA Test Kit have?
The Microsomal EIA Test Kit received FDA 510(k) clearance under K951364 on November 20, 1995, and is classified as a Class II medical device under regulation 866.5870.