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510(k) K012478

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER by I-Stat Corp. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
August 2, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by I-Stat Corp.

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  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)
  • K973292 — I-STAT SYSTEM (October 20, 1997)
  • K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZER (May 10, 1994)
  • K936081 — I-STAT TESTS FOR ACID-BASE PARAMETERS (February 24, 1994)
  • K934642 — I-STAT IONIZED CALCIUM TEST (December 17, 1993)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)

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