I-Stat Corp.
East Windsor, NJ, US
I-Stat Corp. appears in FDA device records in East Windsor, NJ. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for I-Stat Corp. between 1989 and 2006. The busiest year on record is 2000, with 3. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | NBC | Substantially Equivalent | |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge | JGS | Substantially Equivalent | |
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | MYT | Substantially Equivalent | |
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET | JJX | Substantially Equivalent | |
| K023582 | I-STAT KAOLIN ACT TEST | JBP | Substantially Equivalent | |
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST | MMI | Substantially Equivalent | |
| K020355 | I-STAT PROTHROMBIN TIME TEST | GJS | Substantially Equivalent | |
| K012478 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER | CHL | Substantially Equivalent | |
| K011478 | I-STAT SYSTEM | KHP | Substantially Equivalent | |
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | CGA | Substantially Equivalent | |
| K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER | JGS | Substantially Equivalent | |
| K992571 | I-STAT SYSTEM | JBP | Substantially Equivalent | |
| K982071 | I-STAT LACTATE TEST | KHP | Substantially Equivalent | |
| K973292 | I-STAT SYSTEM | CGL | Substantially Equivalent | |
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER | CHL | Substantially Equivalent | |
| K936081 | I-STAT TESTS FOR ACID-BASE PARAMETERS | CHL | Substantially Equivalent | |
| K934642 | I-STAT IONIZED CALCIUM TEST | JFP | Substantially Equivalent | |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | JJR | Substantially Equivalent | |
| K921477 | I-STAT(TM) LEVELS 1,2,3 CONTROLS | JJY | Substantially Equivalent | |
| K912387 | I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK | JGS | Substantially Equivalent | |
| K894914 | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK | JGS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- JBPActivated Whole Blood Clotting Time
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- JFPElectrode, Ion Specific, Calcium
- JGSElectrode, Ion Specific, Sodium
- JJRElectrolyte Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- MMIImmunoassay Method, Troponin Subunit
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NBCTest, Natriuretic Peptide
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain