Home / 510(k) Clearances / K823704

510(k) K823704

ATS GRAM STAIN CONTROL SLIDE by Alpha-Tec Systems, Inc. — Product Code LJG

K823704 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS GRAM STAIN CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 9, 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 Alpha-Tec Systems, Inc.

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)
  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)
  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)

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)
  • 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)

FDA data resources