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510(k) K771925

KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP by Harleco — Product Code KES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1977
Date Received
October 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coverslips, Microscope Slide
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Harleco

  • K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056) (February 12, 1982)
  • K813427 — ULTRACHEM GLUC-DH (December 31, 1981)
  • K813038 — ULTRACHEM TP, ITEM #64974 (November 10, 1981)
  • K813043 — ULTRACHEM CREA ITEM #64972 (November 10, 1981)
  • K813041 — ULTRAZYME-GT, ITEM #64959 & 65032 (November 10, 1981)
  • K813040 — ULTRACHEM CA, ITEM #64975 (November 10, 1981)
  • K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048 (November 10, 1981)
  • K813044 — ULTRACHEM ALB, ITEM #64970 (November 10, 1981)
  • K813039 — ULTRACHEM E-CHOL, ITEM #65025 (November 10, 1981)
  • K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (October 2, 1981)

Other clearances for product code KES

  • K882881 — SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER (July 28, 1988)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)