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510(k) K812193

KOH MOUNTING FLUID by American Scientific Products — Product Code LEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
August 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mounting Media
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code LEB

  • K842986 — REFRAX MOUNTING MEDIUM (August 21, 1984)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K811799 — CLEAR-MOUNT (July 31, 1981)
  • K760838 — LACTO-PHENOL COTTON BLUE MOUNTING FL. (November 16, 1976)