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510(k) K934641

I-STAT CONTROL LEVELS 1,2,3 by I-Stat Corp. — Product Code JJR

K934641 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "I-STAT CONTROL LEVELS 1,2,3". The FDA issued a decision of Substantially Equivalent on December 9, 1993. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. I-Stat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1993
Date Received
September 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrolyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K934642 — I-STAT IONIZED CALCIUM TEST (December 17, 1993)

Other clearances for product code JJR

  • K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (April 27, 1999)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K955630 — RNA MEDICAL HEMAT CONTROL (March 1, 1996)
  • K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (May 2, 1995)
  • K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (October 4, 1994)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K902266 — ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (June 6, 1990)
  • K894576 — CIBA CORNING CERTAIN LYTE (October 30, 1989)
  • K895582 — QCLYTE PROTEIN-BASED ISE CONTROL (October 4, 1989)
  • K881773 — DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (June 10, 1988)

FDA data resources