K982442 is an FDA 510(k) clearance for the C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK). This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Care Wise Medical Products Corp. (Morgan Hill, US). The FDA issued a Cleared decision on August 25, 1998, 42 days after receiving the submission on July 14, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K982442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1998 |
| Decision Date | August 25, 1998 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |