K141220 is an FDA 510(k) clearance for the APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE. This device is classified as a Instrumentation For Clinical Multiplex Test Systems (Class II - Special Controls, product code NSU).
Submitted by Thermo Fisher Scientific (Life Technologies Holdin (Singapore, SG). The FDA issued a Cleared decision on May 22, 2014, 10 days after receiving the submission on May 12, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2570. 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, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. This Instrumentation Is Used With Specific Assays To Comprise An Assay Test System To Measure Multiple Analytes Of A Similar Chemical Nature For De.
| 510(k) Number | K141220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2014 |
| Decision Date | May 22, 2014 |
| Days to Decision | 10 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NSU — Instrumentation For Clinical Multiplex Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.2570 |
| Definition | 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, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. This Instrumentation Is Used With Specific Assays To Comprise An Assay Test System To Measure Multiple Analytes Of A Similar Chemical Nature For De |