The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Ise Calibrators For Corning 600 Series Analyzers.
| Device ID | K930796 |
| 510k Number | K930796 |
| Device Name: | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS |
| Classification | Equipment, Rocket Immunoelectrophoresis |
| Applicant | ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Contact | Brian J Young |
| Correspondent | Brian J Young ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JZX |
| CFR Regulation Number | 866.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1994-01-13 |