Api Uniscept Micro-Mic Ceftriaxone/Uniscept Mic
by Analytical Products, Inc. 510(k)
Active
510(k) K860369
Overview
This device is a Manual Antimicrobial Susceptibility Test System, as defined by its classification name and product code JWY. It is designed for use in microbiology laboratory settings to determine the susceptibility of microorganisms to antimicrobial agents.
The device is supplied as a reusable system and has received FDA 510(k) clearance under number K860369, with a traditional clearance pathway and substantially equivalent decision. It is classified as a Class II device under regulation 866.1640 and is subject to special controls, with no third-party review involved.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860369 | Date11 Mar 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JWY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Analytical Products, Inc.
Questions
What is the API UNISCEPT MICRO-MIC used for?
The API UNISCEPT MICRO-MIC is a manual antimicrobial susceptibility test system designed for use in microbiology laboratory settings to determine the susceptibility of microorganisms to antimicrobial agents, as defined by its classification name and product code JWY.
Is the API UNISCEPT MICRO-MIC reusable or single-use?
The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and reprocessing between tests, as stated in the device description.
What regulatory pathway was used for the API UNISCEPT MICRO-MIC?
The API UNISCEPT MICRO-MIC received FDA 510(k) clearance under number K860369 through a traditional clearance pathway, with a substantially equivalent decision and no third-party review involved.