Applied Biosystems 7500 Fast DX
FDA 510(k) K082562 · Applied Biosystems, Inc.
510(k) numberK082562
Submission
- Device name
- Applied Biosystems 7500 Fast DX
- Applicant
- Applied Biosystems, Inc.
Foster City, CA, US - Received
- September 4, 2008
- Decision date
- September 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing…
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| K110786 | Esensor Warfarin Sensitivity Saliva TestNSU · Traditional | GenMark Diagnostics, Inc. | 12/02/2011SE |
| K093128 | Illumina Beadxpress SystemNSU · Traditional | Illumina, Inc. | 04/28/2010SE |
| K080995 | Modification to Affymetrix Genechip Microarray Instrumentation SystemNSU · Traditional | Affymetrix, Inc. | 07/30/2008SE |
| K073506 | Luminex LX 100/200 InstrumentNSU · Traditional | Luminex Corp. | 03/07/2008SE |
Questions and answers
When was Applied Biosystems 7500 Fast DX cleared by the FDA?
Applied Biosystems 7500 Fast DX (K082562) received a 510(k) decision of Substantially Equivalent on September 30, 2008, 26 days after the submission was received.
What is the product code of K082562?
The FDA product code is NSU – Instrumentation For Clinical Multiplex Test Systems, a Class II (moderate risk) device regulated under 21 CFR 862.2570.