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510(k) K901450

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB by Intl. Immunoassay Laboratories, Inc. — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
March 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, 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)
  • K903508 — LABELLING CHANGES TO IMPRES-MB-X (September 7, 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)
  • K883223 — CHECK-MM (September 30, 1988)
  • K883222 — ISOFOR-MM (TM) (September 30, 1988)

Other clearances for product code JHT

  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI (May 28, 1999)
  • K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (April 12, 1993)
  • K904866 — COULTER CK-MB ISOENZYME REAGENT (December 13, 1990)
  • K904721 — DSL CK-MB (DSL #3200) (December 13, 1990)
  • K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (February 16, 1990)
  • K881168 — CREATINE KINASE (CK) ISOENZYME MB (November 10, 1988)
  • K874284 — SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (January 21, 1988)
  • K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (September 16, 1987)
  • K872598 — MICROMI-CK(TM) (August 3, 1987)