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510(k) K934641

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

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

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Other clearances for product code JJR

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  • 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)