The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Titertek Twinreader 78-630-00.
| Device ID | K844567 |
| 510k Number | K844567 |
| Device Name: | TITERTEK TWINREADER 78-630-00 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Contact | Joy F Poppe |
| Correspondent | Joy F Poppe FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-03-21 |