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510(k) K890996

LD1 ISOENZYME REAGENT KIT by Trace Scientific , Ltd. — Product Code JGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

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Other clearances for product code JGF

  • K981338 — LD-1 (May 18, 1998)
  • K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION (February 5, 1993)
  • K914261 — ABBOTT QUICKSTART LD-1,#5A30 (October 21, 1991)
  • K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT (May 13, 1987)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)