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510(k) K984269

DBEST OCCULT BLOOD TEST KIT by Ameritek, Inc. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1999
Date Received
October 22, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
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  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)
  • K973957 — DBEST ONE-STEP HCG SERUM/URINE TEST (December 17, 1997)

Other clearances for product code KHE

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  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)