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510(k) K950186

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM by Miles, Inc. — Product Code JHW

K950186 is an FDA 510(k) premarket notification submitted by Miles, Inc. for the device "CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 1995. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Miles, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
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)
  • 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)
  • K943376 — OPERA SYSTEM (September 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)
  • K933475 — TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)
  • K933478 — TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)

Other clearances for product code JHW

  • K162526 — Creatine Kinase-MB (May 26, 2017)
  • K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (July 18, 2014)
  • K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL (August 22, 2012)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K003158 — ROCHE DIAGNOSTICS CK-MB (December 18, 2000)
  • K961501 — ELECSYS CK-MB (June 11, 1996)
  • K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (February 22, 1995)
  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K935924 — AXSYM CK-MB (June 21, 1994)
  • K931050 — CARDIO REP CK ISOENZYME KIT - 3310 (April 20, 1993)

FDA data resources