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510(k) K822604

ACID FAST QUALITY CONTROL SLIDES by Medastat Scientific Corp. — Product Code LJG

K822604 is an FDA 510(k) premarket notification submitted by Medastat Scientific Corp. for the device "ACID FAST QUALITY CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Medastat Scientific Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1982
Date Received
August 27, 1982
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 Medastat Scientific Corp.

  • K931849 — PARAPREP (December 2, 1993)
  • K831408 — DNA FLOR (July 28, 1983)

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