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510(k) K881351

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 by Intl. Immunoassay Laboratories, Inc. — Product Code JHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1988
Date Received
March 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Cpk Or 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)
  • 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)

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  • K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (October 18, 2013)
  • K070835 — OLYMPUS CK-MB REAGENT (June 4, 2007)
  • K022757 — SPIFE CK KIT, MODEL 3332, 3333 (October 11, 2002)
  • K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (August 29, 2002)
  • K974421 — ELECSYS CK-MB STAT (December 17, 1997)
  • K970343 — MMB METHOD (February 14, 1997)
  • K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (June 18, 1996)