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510(k) K954733

ACCESS CORTISOL ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc. — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1995
Date Received
October 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

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  • K052359 — IBL CORTISOL LIA TEST KIT (October 3, 2005)
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  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)