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510(k) K855237

BIOTEL (TM)/ KIDNEY by American Diagnostic Corp. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
December 31, 1985
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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  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
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