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510(k) K964015

INDICARD TEST by Litmus Concepts, Inc. — Product Code MJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1997
Date Received
October 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Gardnerella Vaginalis
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Litmus Concepts, Inc.

  • K962718 — FEMEXAM TESTCARD (February 7, 1997)

Other clearances for product code MJM

  • K923133 — AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (September 25, 1992)