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510(k) K962718

FEMEXAM TESTCARD by Litmus Concepts, Inc. — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1997
Date Received
July 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

Other clearances by Litmus Concepts, Inc.

  • K964015 — INDICARD TEST (June 19, 1997)

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