The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Ise Calibrant A & B, Ise Liquid Reagent For Paramax Clinak Systems.
| Device ID | K960085 |
| 510k Number | K960085 |
| Device Name: | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-03-11 |
| Summary: | summary |