The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat(tm) Levels 1,2,3 Controls.
| Device ID | K921477 |
| 510k Number | K921477 |
| Device Name: | I-STAT(TM) LEVELS 1,2,3 CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | I-STAT CORP. 436 HAZELDEAN ROAD KANATA Ontario K2l 1t9, Canada, CA |
| Contact | Robert F Martin |
| Correspondent | Robert F Martin I-STAT CORP. 436 HAZELDEAN ROAD KANATA Ontario K2l 1t9, Canada, CA |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-30 |
| Decision Date | 1992-11-02 |