K052794 is an FDA 510(k) clearance for the ETI-MAX 3000. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on March 31, 2006, 179 days after receiving the submission on October 3, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K052794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2005 |
| Decision Date | March 31, 2006 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |