K895872 is an FDA 510(k) clearance for the LAN.0800Q/2800Q. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on October 17, 1989, 13 days after receiving the submission on October 4, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K895872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1989 |
| Decision Date | October 17, 1989 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBF — Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |