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510(k) K883208

HISTO-CHECK SLIDES by Val Tech Diagnostics, Inc. — Product Code LJG

K883208 is an FDA 510(k) premarket notification submitted by Val Tech Diagnostics, Inc. for the device "HISTO-CHECK SLIDES". The FDA issued a decision of Substantially Equivalent on August 25, 1988. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Val Tech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1988
Date Received
July 29, 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 Val Tech Diagnostics, Inc.

  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883569 — HISTO-CHECK GRAM NEGATIVE SLIDES (October 6, 1988)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883684 — HERPES VIRUS CONTROL SLIDES (September 28, 1988)
  • K883232 — HISTONE REACTIVE ANA (September 7, 1988)
  • K871395 — DUAL SUBSTRATE ANA (April 20, 1987)
  • K864668 — ANA TEST KIT (March 12, 1987)
  • K870732 — RAT LIVER NUCLEI TEST SYSTEM (March 10, 1987)

Other clearances for product code LJG

  • K943228 — MICROSPORIDIUM CONTROL SET (October 27, 1994)
  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890670 — CRYPTOSPORIDIUM 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)
  • 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)

FDA data resources