The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc-15bt.
| Device ID | K020150 |
| 510k Number | K020150 |
| Device Name: | CRC-15BT |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Mary Anne Dell |
| Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-16 |
| Decision Date | 2002-08-02 |
| Summary: | summary |