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510(k) K924893

MICROSPORIDIUM CONTROL SLIDE by Scientific Device Laboratory, Inc. — Product Code LJG

K924893 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "MICROSPORIDIUM CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
September 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Quality Control Slides
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K895848 — PRESSURE STEAM STERILIZERS (December 11, 1989)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K884011 — SNAP N' STAIN IRON STAIN (October 6, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K881598 — SDL TRICHROME STAIN (May 4, 1988)
  • K840506 — HAEMOPHILUS INFLUENZAE TYPE B (April 4, 1984)

Other clearances for product code LJG

  • K943228 — MICROSPORIDIUM CONTROL SET (October 27, 1994)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)
  • K883569 — HISTO-CHECK GRAM NEGATIVE SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883208 — HISTO-CHECK SLIDES (August 25, 1988)

FDA data resources