The following data is part of a premarket notification filed by Thermo Fisher Scientific (life Technologies Holdin with the FDA for Applied Biosystems 7500 Fast Dx Real-time Pcr Instrument With Sds Software.
| Device ID | K141220 |
| 510k Number | K141220 |
| Device Name: | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, NO. 07-06 Singapore, SG 739256 |
| Contact | Nikki Arora |
| Correspondent | Nikki Arora THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, NO. 07-06 Singapore, SG 739256 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2014-05-22 |
| Summary: | summary |