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510(k) K863333

AVL ISE-TROL ELECTROLYTE CONTROL by Avl Scientific Corp. — Product Code JJR

K863333 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL ISE-TROL ELECTROLYTE CONTROL". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
August 28, 1986
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 Avl Scientific Corp.

  • K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (June 19, 2000)
  • K000103 — AVL OPTI R ANALYZER (March 20, 2000)
  • K993837 — AVL OPTI CRITICAL CARE ANALYZER (December 16, 1999)
  • K990092 — AVL OMNI MODULAR ANALYZER (January 29, 1999)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • K974784 — AVL OPTI CRITICAL CARE ANALYZER (February 24, 1998)
  • K974822 — AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (January 22, 1998)
  • K972733 — AVL OMNI ANALYZER (September 9, 1997)
  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER (November 29, 1996)

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)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)
  • 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)

FDA data resources