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510(k) K882741

ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES by Nichols Institute Diagnostics — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
July 1, 1988
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

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  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)
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  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
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