Microscan Rapid/S Plus Gram-Negative Mic Combo Panels With Gentamicin (0.12-32 Ug/Ml)
by Dade Behring, Inc. 510(k)
Active
510(k) K020185
Overview
The Microscan Rapid/S Plus Gram-Negative Mic Combo Panels are an automated antimicrobial susceptibility test system. This device is designed to determine the susceptibility of Gram-negative bacteria to antimicrobial agents, specifically including Gentamicin in concentrations ranging from 0.12 to 32 ug/ml.
This device is categorized as a Class 2 medical device under regulation number 866.1645. It has received FDA 510(k) clearance for use in microbiology settings. The product is identified by K-number K020185.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020185 | Date6 Feb 2002 | 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- Withdrawn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
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the primary function of the Microscan Rapid/S Plus panels?
This device is an automated antimicrobial susceptibility test system designed for use in microbiology settings. It determines the susceptibility of Gram-negative bacteria to specific antimicrobial agents, including Gentamicin in concentrations ranging from 0.12 to 32 ug/ml.
What is the regulatory status of this device?
The Microscan Rapid/S Plus Gram-Negative MIC Combo Panels are classified as a Class 2 medical device under regulation number 866.1645. The device has received FDA 510(k) clearance, identified by K-number K020185, following a traditional submission process.
Who is the manufacturer of this susceptibility test system?
The device is manufactured by Dade Behring, Inc., located in West Sacramento, California. The product was cleared for use in microbiology laboratories to provide automated testing for bacterial susceptibility.