K842512 is the FDA 510(k) clearance record for EXACTA-FILM, cleared for Ardent Intl., Inc. on . FDA records list 3 510(k) clearances for Ardent Intl., Inc., from to . As of , FDA records show no recalls naming K842512.
Clearance record
- Decision date
- Received
- (0 days to decision)
- Review panel
- Unknown
- Applicant
- Ardent Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
- Third party review
- No
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.