Home / 510(k) Clearances / K943376

510(k) K943376

OPERA SYSTEM by Miles, Inc. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
July 13, 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 Miles, Inc.

  • K950292 — FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (May 2, 1995)
  • K950353 — TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (April 20, 1995)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • K945655 — CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC T (January 5, 1995)
  • K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (December 14, 1994)
  • K941156 — TECHNISON AXON SYSTEM (April 26, 1994)
  • K933682 — DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS (April 12, 1994)
  • K935287 — IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM (January 3, 1994)
  • K933478 — TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)
  • K933475 — TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)

Other clearances for product code JJC

  • K945915 — AVL OMNI ANALYZER (April 5, 1995)
  • K945584 — NOVA 16 ANALYZER (February 8, 1995)
  • 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)