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510(k) K915727

ACTH IRMA KIT II MITSUBISHI YUKA by Mitsubishi Yuka America, Inc. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
December 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type

Other clearances by Mitsubishi Yuka America, Inc.

  • K912536 — CALCITONIN KIT MITSUBISHI YUKA (July 18, 1991)

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  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)