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510(k) K960491

MICRO HAEMATOCRIT CENTRIFUGE by Hawksley & Sons , Ltd. — Product Code CKG

K960491 is an FDA 510(k) premarket notification submitted by Hawksley & Sons , Ltd. for the device "MICRO HAEMATOCRIT CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
February 1, 1996
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)
  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)
  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)
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FDA data resources