The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging Ivb 1000 Well Chamber.
| Device ID | K013548 |
| 510k Number | K013548 |
| Device Name: | STANDARD IMAGING IVB 1000 WELL CHAMBER |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-24 |
| Decision Date | 2001-11-09 |
| Summary: | summary |