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510(k) K920970

BACTIDROP KOH (10%) by Remel Co. — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
March 2, 1992
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

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Other clearances for product code JTS

  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (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)
  • K883061 — ATS PARA-SET CARBOL-XYLENE SOLUTION (August 17, 1988)