The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Capintec Crc 55t Series Dose Calibrators, Models Crc 55tr, Crc 55tpet And Crc 55tw.
| Device ID | K101452 |
| 510k Number | K101452 |
| Device Name: | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Mary Anne Dell |
| Correspondent | Mary Anne Dell CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-25 |
| Decision Date | 2010-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859942006027 | K101452 | 000 |
| 00859942006010 | K101452 | 000 |
| 00859942006003 | K101452 | 000 |