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510(k) K945915

AVL OMNI ANALYZER by Avl Scientific Corp. — Product Code JJC

K945915 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL OMNI ANALYZER". The FDA issued a decision of Substantially Equivalent on April 5, 1995. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1995
Date Received
December 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
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 JJC

  • K945584 — NOVA 16 ANALYZER (February 8, 1995)
  • K943376 — OPERA SYSTEM (September 14, 1994)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (April 9, 1990)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (November 15, 1988)
  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)
  • K854345 — TECHNICON RA-500 SYSTEM (November 26, 1985)

FDA data resources