The following data is part of a premarket notification filed by Tecan U.s., Ltd. with the FDA for Slt Microplate Washer.
Device ID | K910740 |
510k Number | K910740 |
Device Name: | SLT MICROPLATE WASHER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | TECAN U.S., LTD. 164 DIMMOCKS MILL RD. P.O. BOX 8101 Hillsborough, NC 27278 |
Contact | Daniel B Roark |
Correspondent | Daniel B Roark TECAN U.S., LTD. 164 DIMMOCKS MILL RD. P.O. BOX 8101 Hillsborough, NC 27278 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-21 |
Decision Date | 1991-03-27 |