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510(k) K981338

LD-1 by Abbott Laboratories — Product Code JGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1998
Date Received
April 13, 1998
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

  • K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION (February 5, 1993)
  • K914261 — ABBOTT QUICKSTART LD-1,#5A30 (October 21, 1991)
  • K890996 — LD1 ISOENZYME REAGENT KIT (May 5, 1989)
  • K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT (May 13, 1987)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)