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510(k) K920918

TMB CHROMOGEN/SUBSTRATE REAGENT SET by Bio Clinic Co. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1992
Date Received
February 28, 1992
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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