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510(k) K881110

LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES by Sigma Diagnostics, Inc. — Product Code LJG

K881110 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on April 12, 1988. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1988
Date Received
March 15, 1988
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 Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX D (August 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

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)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • 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)

FDA data resources