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510(k) K961965

SURE CHECK PREGNANCY TEST by Chembio Diagnostic Systems, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1996
Date Received
May 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K923925 — HCG STAT-PAK (December 24, 1992)

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