The following data is part of a premarket notification filed by I-stat Corp. with the FDA for Modification To: I-stat Portable Clinical Analyzer.
| Device ID | K012478 |
| 510k Number | K012478 |
| Device Name: | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | I-STAT CORP. 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Contact | Paul Vanderwerf |
| Correspondent | Paul Vanderwerf I-STAT CORP. 104 WINDSOR CENTER DR. East Windsor, NJ 08520 |
| Product Code | CHL |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHA |
| Subsequent Product Code | JBP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JPI |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2001-08-20 |
| Summary: | summary |