Atlas FDA

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

FDA 510(k) clearance K001387 · decided 2000-10-05

Clearance details

K-number
K001387
Device name
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
Applicant
I-Stat Corp.
Decision
Substantially Equivalent
Date received
2000-05-02
Decision date
2000-10-05
Days to decision
156 days
Clearance type
Traditional
Product code
CGA
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
East Windsor, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests f recall (Z-1973-2012)Abbott Point Of Care Inc.2012-07-09
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. Th recall (Z-1974-2012)Abbott Point Of Care Inc.2012-07-09
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tes recall (Z-1975-2012)Abbott Point Of Care Inc.2012-07-09
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 recall (Z-1976-2012)Abbott Point Of Care Inc.2012-07-09
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degre recall (Z-1977-2012)Abbott Point Of Care Inc.2012-07-09
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model recall (Z-1978-2012)Abbott Point Of Care Inc.2012-07-09
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. Th recall (Z-0597-2011)Abbott Point Of Care Inc.2010-12-10
Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2 recall (Z-0598-2011)Abbott Point Of Care Inc.2010-12-10
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (m recall (Z-2462-2010)Abbott Point of Care Inc.2010-09-23
Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer recall (Z-1133-2010)Abbott Point of Care Inc.2010-03-15
i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer recall (Z-0865-2010)Abbott Point of Care Inc.2010-02-26
i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. T recall (Z-0812-2010)Abbott Point of Care Inc.2010-02-24
Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. recall (Z-2328-2009)Abbott Point of Care Inc.2009-09-30