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510(k) K912231

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT by Intl. Immunoassay Laboratories, Inc. — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1991
Date Received
May 20, 1991
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)
  • K903441 — MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS (November 6, 1990)
  • K903508 — LABELLING CHANGES TO IMPRES-MB-X (September 7, 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)

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  • 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)