The following data is part of a premarket notification filed by Care Wise Medical Products Corp. with the FDA for C-trak Automatic Analyzer (name Change From Oncoprobe Ii To C-trak).
| Device ID | K982442 |
| 510k Number | K982442 |
| Device Name: | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) |
| Classification | Probe, Uptake, Nuclear |
| Applicant | CARE WISE MEDICAL PRODUCTS CORP. P.O. BOX 1655 Morgan Hill, CA 95038 -1655 |
| Contact | Robin A Wise |
| Correspondent | Robin A Wise CARE WISE MEDICAL PRODUCTS CORP. P.O. BOX 1655 Morgan Hill, CA 95038 -1655 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-14 |
| Decision Date | 1998-08-25 |
| Summary: | summary |