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510(k) K801076

WAKO PHOSPHOLIPIDS TEST by Wako Pure Chemical Industries, Ltd. — Product Code CEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
May 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Device Class
Class I
Regulation Number
862.1575
Review Panel
CH
Submission Type

Other clearances by Wako Pure Chemical Industries, Ltd.

  • K842221 — WAKO GLUCOSE C (July 12, 1984)
  • K813366 — AMMONIA TEST (December 22, 1981)
  • K801891 — WAKO TRIGLYCERIDE-G TEST (September 16, 1980)
  • K801834 — WAKO HDL CHOLESTEROL TEST (September 16, 1980)
  • K791597 — WAKO TRIGLYCERIDE (September 17, 1979)

Other clearances for product code CEL

  • K905829 — DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (January 30, 1991)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)