Aladin (TM)
FDA 510(k) K865062 · Analytical Products, Inc.
510(k) numberK865062
Submission
- Device name
- Aladin (TM)
- Applicant
- Analytical Products, Inc.
Plainview, NY, US - Received
- December 24, 1986
- Decision date
- March 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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|---|---|---|---|
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| K191914 | Thermo Scientific Sensititre ARIS HiQ SystemLRG · Traditional | Thermo Fisher Scientific | 11/06/2019SE |
| K110583 | Sensititre OptireadLRG · Traditional | Trek Diagnostic Systems, Ltd. | 09/22/2011SE |
| K103532 | Autoreader 2LRG · Traditional | Trek Diagnostic Systems | 08/26/2011SE |
| K111677 | Microscan(R) Microstrep Plus(R)LRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/04/2011SE |
| K111205 | Microscan (R) Microstrep Plus (R) PanelsLRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/20/2011SE |
| K101425 | Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesLRG · Traditional | Siemens Healthcare Diagnostics | 09/10/2010SE |
| K081013 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test Cefoxitin ScreenLRG · Traditional | Siemens Healthcare Diagnostics | 09/08/2008SE |
| K071316 | Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Streptomycin…LRG · Traditional | Dade Behring, Inc. | 08/20/2007SE |
| K063299 | Microscan Microstrep Plus Panel-ClarithromycinLRG · Traditional | Dade Behring, Inc. | 11/27/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924814 | Api 20E/UNISCEPT 20EJSS · Traditional | 03/11/1993SE |
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
Questions and answers
When was Aladin (TM) cleared by the FDA?
Aladin (TM) (K865062) received a 510(k) decision of Substantially Equivalent on March 25, 1987, 91 days after the submission was received.
What is the product code of K865062?
The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.