Aladin (TM)
by Analytical Products, Inc. 510(k)
Active
510(k) K865062
Overview
The Aladin (TM) is an instrument for auto reader and interpretation of overnight susceptibility systems used in microbiology. It is designed to automate the reading and interpretation of susceptibility testing results.
The device is manufactured by Analytical Products, Inc. and received FDA 510(k) clearance on March 25, 1987. It is a Class II medical device with product code LRG and is regulated under 21 CFR 866.1640. The device is supplied in various models as indicated by the K865062 clearance number.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK865062 | Date25 Mar 1987 | 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- Withdrawn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
- LRG
- 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 ALADIN instrument used for?
The ALADIN instrument is designed to automate the reading and interpretation of susceptibility testing results from overnight systems used in microbiology laboratories. It helps streamline the process of determining how microorganisms respond to various antimicrobial agents.
How is the ALADIN device supplied?
The ALADIN device is manufactured by Analytical Products, Inc. and is available in various models as indicated by the K865062 clearance number. The device is supplied as a Class II medical device with product code LRG, regulated under 21 CFR 866.1640.
What is the regulatory status of the ALADIN instrument?
The ALADIN instrument received FDA 510(k) clearance on March 25, 1987, with the decision code SESE indicating it was determined to be substantially equivalent to predicate devices. It is manufactured by Analytical Products, Inc. and is regulated as a Class II medical device.
Is the ALADIN device reusable or single-use?
The device data does not specify whether the ALADIN instrument is reusable or single-use. As an automated instrument for reading susceptibility testing results, it is likely designed for multiple uses in a laboratory setting, but specific information about reusability is not provided in the available data.