Submission Details
| 510(k) Number | K880090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 12, 1988 |
| Decision Date | March 15, 1988 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K880090 is an FDA 510(k) clearance for the ION TRAP DETECTOR, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Finnigan Corp. (San Jose, US). The FDA issued a Cleared decision on March 15, 1988, 63 days after receiving the submission on January 12, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2860.
| 510(k) Number | K880090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 12, 1988 |
| Decision Date | March 15, 1988 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DOP — Mass Spectrometer, Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2860 |