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510(k) K863099

ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT by Abbott Laboratories — Product Code JJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
August 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oncometer, Plasma, For Clinical Use
Device Class
Class I
Regulation Number
862.2720
Review Panel
CH
Submission Type

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Other clearances for product code JJK

  • K823196 — SPECIAL CONTROL SERUM FOR HDL-CHOLES (November 29, 1982)
  • K802120 — HEPA-SHURE -L (October 20, 1980)
  • K760975 — WEIL ONCOMETER (IL 186) (January 12, 1977)