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510(k) K890718

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

K890718 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "GRAM STAIN CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on March 16, 1989. 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
March 16, 1989
Date Received
February 13, 1989
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)
  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K895848 — PRESSURE STEAM STERILIZERS (December 11, 1989)
  • K890670 — CRYPTOSPORIDIUM 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)
  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • 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)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883208 — HISTO-CHECK SLIDES (August 25, 1988)

FDA data resources