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510(k) K884047

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY by Disease Detection International, Inc. — Product Code LYF

K884047 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY". The FDA issued a decision of Substantially Equivalent on March 14, 1989. The device falls under product code LYF (Pneumocystis Carinii), a Class II device regulated under 21 CFR 866.3780. Disease Detection International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1989
Date Received
September 26, 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

Other clearances by Disease Detection International, Inc.

  • K943252 — PRO-STEP LH OVULATION PREDICTION TEST (October 25, 1994)
  • K925303 — PRO-STEP PT HCG (June 15, 1993)
  • K925125 — PRO-STEP HCG (January 13, 1993)
  • K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (July 19, 1991)
  • K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST (September 5, 1990)
  • K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT (August 9, 1990)
  • K895912 — IMMUNOCARD HCG II-S TEST KIT (December 1, 1989)
  • K896109 — IMMUNOCARD STREP A TEST (November 29, 1989)
  • K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT (April 10, 1989)
  • K884247 — MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (April 10, 1989)

Other clearances for product code LYF

  • K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (August 10, 1999)
  • 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)
  • K881608 — MERIFLUOR(TM) PNEUMOCYSTIS (August 4, 1988)

FDA data resources