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510(k) K871240

ABBOTT A-GENT LD-1 ISOZYME REAGENT by Abbott Laboratories — Product Code JGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1987
Date Received
March 27, 1987
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)
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