The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Ise Reagents For Olympus Au 800/au5200 Chemistry Systems.
| Device ID | K972004 |
| 510k Number | K972004 |
| Device Name: | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-06-16 |
| Summary: | summary |