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510(k) K953606

BEST PREGNANCY TEST by Ameritek, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
August 2, 1995
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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  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
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  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)

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