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510(k) K980782

STAT-SIMPLE PYLORI by Saliva Diagnostic Systems, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1998
Date Received
March 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Saliva Diagnostic Systems, Inc.

  • K962721 — EVIDENCE PREGNANCY TEST (October 1, 1996)
  • K942435 — SALIVA SAMPLER (August 21, 1995)

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