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510(k) K002638

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT by Future Diagnostics B.V. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2001
Date Received
August 24, 2000
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 Future Diagnostics B.V.

  • K000471 — FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT (April 11, 2000)

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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)
  • K940271 — INCSTAR ACTH IRMA (August 2, 1994)