The following data is part of a premarket notification filed by Applied Biosystems Inc with the FDA for Applied Biosystems 7500 Fast Dx.
| Device ID | K082562 |
| 510k Number | K082562 |
| Device Name: | APPLIED BIOSYSTEMS 7500 FAST DX |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | APPLIED BIOSYSTEMS INC 850 LINCOLN CENTER DRIVE Foster City, CA 94404 -1128 |
| Contact | John D'angelo |
| Correspondent | John D'angelo APPLIED BIOSYSTEMS INC 850 LINCOLN CENTER DRIVE Foster City, CA 94404 -1128 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-04 |
| Decision Date | 2008-09-30 |
| Summary: | summary |