The following data is part of a premarket notification filed by Tecan U.s., Ltd. with the FDA for Profiblot.
| Device ID | K933996 |
| 510k Number | K933996 |
| Device Name: | PROFIBLOT |
| Classification | Slide Stainer, Automated |
| Applicant | TECAN U.S., LTD. P.O. BOX 8101 Hillsborough, NC 27278 |
| Contact | Daniel B Roark |
| Correspondent | Daniel B Roark TECAN U.S., LTD. P.O. BOX 8101 Hillsborough, NC 27278 |
| Product Code | KPA |
| CFR Regulation Number | 864.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-01-28 |