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510(k) K840087

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

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.

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  • K840189 — TOTAL CHOLESTEROL REAGENT SET (March 23, 1984)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)
  • K840991 — PRESERV BUFFERED GLYCEROL SALINE (March 23, 1984)
  • K840968 — PRESERV TRANSPORT & CULTURE PACK (March 23, 1984)
  • K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS (March 23, 1984)
  • K840990 — PRESERV CARY BLAIR TRANSPORT PACK (March 23, 1984)
  • K840278 — HDL CHOLESTEROL CONTROLS-LEVELS (March 23, 1984)
  • K840217 — CHOLESTEROL AQUEOUS STANDARD (March 23, 1984)

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  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)