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510(k) K883061

ATS PARA-SET CARBOL-XYLENE SOLUTION by Alpha-Tech Systems, Inc. — Product Code JTS

K883061 is an FDA 510(k) premarket notification submitted by Alpha-Tech Systems, Inc. for the device "ATS PARA-SET CARBOL-XYLENE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 17, 1988. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1988
Date Received
July 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

Other clearances for product code JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)

FDA data resources