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510(k) K904400

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION by Meridian Diagnostics, Inc. — Product Code LYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1990
Date Received
September 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumocystis Carinii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

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Other clearances for product code LYF

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  • K923349 — FUNGI FLUOR KIT (October 20, 1992)
  • K905504 — STAINING SYSTEM FOR PNEUMOCYSTIS CARINII (June 28, 1991)
  • K890768 — PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (March 21, 1989)
  • K884047 — FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY (March 14, 1989)
  • K881608 — MERIFLUOR(TM) PNEUMOCYSTIS (August 4, 1988)