The following data is part of a premarket notification filed by Abbott Pont Of Care Inc with the FDA for I-stat Lactate Test/i-sat Cg4+cartridge.
| Device ID | K112430 |
| 510k Number | K112430 |
| Device Name: | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | ABBOTT PONT OF CARE INC 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Contact | Yuko Hartley |
| Correspondent | Yuko Hartley ABBOTT PONT OF CARE INC 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-12-20 |
| Summary: | summary |