The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc-77thr.
| Device ID | K162394 |
| 510k Number | K162394 |
| Device Name: | CRC-77tHR |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 |
| Contact | Mary Anne Yusko |
| Correspondent | Mary Anne Yusko Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859942006065 | K162394 | 000 |