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510(k) K960095

BACTIDROP CALCOFLUOR WHITE by Remel Co. — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1996
Date Received
January 11, 1996
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

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • 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)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)