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510(k) K840087

PRESERV GOMORI TRICHROME STAIN 125/500 by Preventive Diagnostics Corp. — Product Code LED

K840087 is an FDA 510(k) premarket notification submitted by Preventive Diagnostics Corp. for the device "PRESERV GOMORI TRICHROME STAIN 125/500". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. Preventive Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
January 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Preventive Diagnostics Corp.

  • K840677 — HDL EZ-TZ3 CHOLESTEROL REAGENT KIT (April 13, 1984)
  • K840676 — PDC HDL EZ-SEP CHOLESTEROL REAGENT (April 4, 1984)
  • K840220 — HDL CHOLESTEROL AQUEOUS STANDARDS (March 23, 1984)
  • K840217 — CHOLESTEROL AQUEOUS STANDARD (March 23, 1984)
  • K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS (March 23, 1984)
  • K840990 — PRESERV CARY BLAIR TRANSPORT PACK (March 23, 1984)
  • K840189 — TOTAL CHOLESTEROL REAGENT SET (March 23, 1984)
  • K840278 — HDL CHOLESTEROL CONTROLS-LEVELS (March 23, 1984)
  • K840991 — PRESERV BUFFERED GLYCEROL SALINE (March 23, 1984)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)

Other clearances for product code LED

  • K051409 — SLIVASURE (August 8, 2005)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K860795 — SPOTTEST CALCOFLUOR WHITE REAGENT (March 12, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)

FDA data resources