The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Reagents For Cobas Ise Module.
| Device ID | K934701 |
| 510k Number | K934701 |
| Device Name: | REAGENTS FOR COBAS ISE MODULE |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-30 |
| Decision Date | 1993-12-02 |