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510(k) K830134

Q-CHECK REAGENT STANDARDS by Lab Ability, Inc. — Product Code LJG

K830134 is an FDA 510(k) premarket notification submitted by Lab Ability, Inc. for the device "Q-CHECK REAGENT STANDARDS". The FDA issued a decision of Substantially Equivalent on January 9, 1983. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Lab Ability, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1983
Date Received
January 9, 1983
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 Lab Ability, Inc.

  • K833407 — SELECTO-DISC NOVOBIOCIN 5UG (December 30, 1983)
  • K832436 — SELECTRO-DISC (September 26, 1983)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K813191 — SHIGELLA SERA-CHEK (December 3, 1981)

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)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883569 — HISTO-CHECK GRAM NEGATIVE 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