K982412 is an FDA 510(k) clearance for the MODIFICATION OF CRIT-LINE MONITOR III (CLM III), a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by In-Line Diagnostics Corp. (Farmington, US). The FDA issued a Cleared decision on October 9, 1998, 88 days after receiving the submission on July 13, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K982412 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1998 |
| Decision Date | October 09, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQS — System, Hemodialysis, Access Recirculation Monitoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |