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510(k) K923349

FUNGI FLUOR KIT by Polysciences, Inc. — Product Code LYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1992
Date Received
July 8, 1992
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

Other clearances by Polysciences, Inc.

  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K780146 — T3 STI KIT (February 23, 1978)

Other clearances for product code LYF

  • K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (August 10, 1999)
  • K905504 — STAINING SYSTEM FOR PNEUMOCYSTIS CARINII (June 28, 1991)
  • K904400 — MERIFLUOR TM PNEUMOCYSTIS MODIFICATION (October 16, 1990)
  • 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)