K000921 is an FDA 510(k) clearance for the BAYER ADVIA IMS SYSTEM; 200 + 3. This device is classified as a Alpha-1-lipoprotein, Antigen, Antiserum, Control (Class II - Special Controls, product code DER).
Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on May 18, 2000, 57 days after receiving the submission on March 22, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5580.
| 510(k) Number | K000921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2000 |
| Decision Date | May 18, 2000 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DER — Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5580 |