Company ยท US
I-Stat Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2006. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 4 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 3 |
| JBP | Activated Whole Blood Clotting Time | 2 |
| KHP | Acid, Lactic, Enzymatic Method | 2 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 |
| MYT | Biosensor, Immunoassay, Cpk Or Isoenzymes | 1 |
| NBC | Test, Natriuretic Peptide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 2006 | K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) I-Stat Corporation | NBC |
| Jan 13, 2006 | K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbot I-Stat Corporation | JGS |
| Dec 15, 2005 | K051433 | I-STAT CREATINE KINASE MB (CK-MB) I-Stat Corporation | MYT |
| Oct 7, 2003 | K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-Stat Corporation | JJX |
| Sep 8, 2003 | K023582 | I-STAT KAOLIN ACT TEST I-Stat Corporation | JBP |
| Sep 2, 2003 | K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST I-Stat Corporation | MMI |
| May 14, 2002 | K020355 | I-STAT PROTHROMBIN TIME TEST I-Stat Corporation | GJS |
| Aug 20, 2001 | K012478 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER I-Stat Corp. | CHL |
| Jul 2, 2001 | K011478 | I-STAT SYSTEM I-Stat Corp. | KHP |
| Oct 5, 2000 | K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp. | CGA |
| Apr 18, 2000 | K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-Stat Corp. | JGS |
| Feb 10, 2000 | K992571 | I-STAT SYSTEM I-Stat Corp. | JBP |
| Jun 29, 1998 | K982071 | I-STAT LACTATE TEST I-Stat Corp. | KHP |
| Oct 20, 1997 | K973292 | I-STAT SYSTEM I-Stat Corp. | CGL |
| May 10, 1994 | K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER I-Stat Corp. | CHL |
| Feb 24, 1994 | K936081 | I-STAT TESTS FOR ACID-BASE PARAMETERS I-Stat Corp., CA | CHL |
| Dec 17, 1993 | K934642 | I-STAT IONIZED CALCIUM TEST I-Stat Corp. | JFP |
| Dec 9, 1993 | K934641 | I-STAT CONTROL LEVELS 1,2,3 I-Stat Corp. | JJR |
| Nov 2, 1992 | K921477 | I-STAT(TM) LEVELS 1,2,3 CONTROLS I-Stat Corp., CA | JJY |
| Jul 1, 1991 | K912387 | I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK I-Stat Corp. | JGS |
| Oct 16, 1989 | K894914 | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK I-Stat Corp. | JGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||