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510(k) K934642

I-STAT IONIZED CALCIUM TEST by I-Stat Corp. — Product Code JFP

K934642 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "I-STAT IONIZED CALCIUM TEST". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. I-Stat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
September 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by I-Stat Corp.

  • K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (August 20, 2001)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (October 5, 2000)
  • K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER (April 18, 2000)
  • 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)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)

Other clearances for product code JFP

  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 14, 2020)
  • K191626 — Stat Profile Prime ES Comp Plus Analyzer System (August 16, 2019)
  • K152327 — EasyLyte Na/K/Cl/Ca Analyzer (December 1, 2016)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZER (November 27, 1996)
  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)
  • K960120 — STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (March 11, 1996)
  • K943091 — EASY LYTE CALCIUM ANALYZER (January 17, 1995)

FDA data resources