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510(k) K011551

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2001
Date Received
May 18, 2001
Clearance Type
Special
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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  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (February 12, 1999)
  • K961965 — SURE CHECK PREGNANCY TEST (June 24, 1996)
  • K923925 — HCG STAT-PAK (December 24, 1992)

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