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510(k) K973957

DBEST ONE-STEP HCG SERUM/URINE TEST by Ameritek, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
October 16, 1997
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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  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983190 — DBEST OPIATES 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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