K972409 is an FDA 510(k) clearance for the AG CHEMISTRY ANALYZER SYSTEM. This device is classified as a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I - General Controls, product code JJG).
Submitted by Landmark Scientific, Inc. (Rockville, US). The FDA issued a Cleared decision on August 28, 1997, 63 days after receiving the submission on June 26, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2140.
| 510(k) Number | K972409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1997 |
| Decision Date | August 28, 1997 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2140 |