The following data is part of a premarket notification filed by Landmark Scientific, Inc. with the FDA for Ag Chemistry Analyzer System.
| Device ID | K972409 |
| 510k Number | K972409 |
| Device Name: | AG CHEMISTRY ANALYZER SYSTEM |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | LANDMARK SCIENTIFIC, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockvilleo, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey LANDMARK SCIENTIFIC, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockvilleo, MD 20852 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-08-28 |
| Summary: | summary |