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510(k) K903508

LABELLING CHANGES TO IMPRES-MB-X by Intl. Immunoassay Laboratories, Inc. — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1990
Date Received
July 31, 1990
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 Intl. Immunoassay Laboratories, Inc.

  • K913380 — MYDAS(TM)-MB2/MYDAS(TM)-MB (April 22, 1992)
  • K913349 — STAMBI-CK (October 23, 1991)
  • K912231 — PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT (July 8, 1991)
  • K903441 — MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS (November 6, 1990)
  • K901450 — MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (May 15, 1990)
  • K890609 — IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) (March 16, 1989)
  • K890543 — IMPRES-MB REAGENT A AND REAGENT B (March 13, 1989)
  • K883432 — IMMUNOCCULT-LXI (October 31, 1988)
  • K883222 — ISOFOR-MM (TM) (September 30, 1988)
  • K883223 — CHECK-MM (September 30, 1988)

Other clearances for product code JHW

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  • 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)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • 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)