The following data is part of a premarket notification filed by Tecan U.s., Inc. with the FDA for Genesis Rmp.
| Device ID | K963268 |
| 510k Number | K963268 |
| Device Name: | GENESIS RMP |
| Classification | Microtitrator, For Clinical Use |
| Applicant | TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709 |
| Contact | Christy Lycan |
| Correspondent | Christy Lycan TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709 |
| Product Code | JRA |
| CFR Regulation Number | 862.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1997-03-18 |