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510(k) K881608

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
April 12, 1988
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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  • K890768 — PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (March 21, 1989)
  • K884047 — FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY (March 14, 1989)