Home / 510(k) Clearances / K991741

510(k) K991741

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 by Biocheck, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1999
Date Received
May 21, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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