K991817 is an FDA 510(k) clearance for the ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM. This device is classified as a Saccharogenic, Amylase (Class II - Special Controls, product code CIJ).
Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 22, 1999, 56 days after receiving the submission on May 27, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K991817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1999 |
| Decision Date | July 22, 1999 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIJ — Saccharogenic, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |