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510(k) K771390

HISTOCHEMICAL AFB DEMONSTRATION by Harleco — Product Code ICL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1977
Date Received
July 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbol Fuchsin
Device Class
Class I
Regulation Number
864.1850
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 ICL

  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)