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510(k) K992252

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 by Chemicon Intl., Inc. — Product Code LYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1999
Date Received
July 6, 1999
Clearance Type
Special
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

  • K923349 — FUNGI FLUOR KIT (October 20, 1992)
  • 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)