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510(k) K820567

TREP CARD EIKEN by Syn-Kit, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843756 — UROPAPER EIKEN 5 (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843754 — UROPAPER EIKEN 7 (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

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