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510(k) K813366

AMMONIA TEST by Wako Pure Chemical Industries, Ltd. — Product Code JID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1981
Date Received
November 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Ammonia
Device Class
Class I
Regulation Number
862.1065
Review Panel
CH
Submission Type

Other clearances by Wako Pure Chemical Industries, Ltd.

  • K842221 — WAKO GLUCOSE C (July 12, 1984)
  • K801891 — WAKO TRIGLYCERIDE-G TEST (September 16, 1980)
  • K801834 — WAKO HDL CHOLESTEROL TEST (September 16, 1980)
  • K801076 — WAKO PHOSPHOLIPIDS TEST (June 30, 1980)
  • K791597 — WAKO TRIGLYCERIDE (September 17, 1979)

Other clearances for product code JID

  • K991371 — CARESIDE AMMONIA (August 3, 1999)
  • K820723 — KODAK EKTACHEM CLINICAL CHEM. NH3 (April 1, 1982)