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510(k) K843756

UROPAPER EIKEN 5 by Syn-Kit, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1984
Date Received
September 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
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)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)
  • K843754 — UROPAPER EIKEN 7 (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

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