The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for I-stat Activated Clotting Time (act) Control Set Level 1 And Level 2, Models 07g82-01, 07g82-02.
| Device ID | K071319 |
| 510k Number | K071319 |
| Device Name: | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 |
| Classification | Plasma, Coagulation Control |
| Applicant | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-06-26 |
| Summary: | summary |