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510(k) K914903

QUICKSTART UREA NITROGEN by Em Diagnostic Systems, Inc. — Product Code CDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1991
Date Received
November 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease, Photometric, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

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  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

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  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
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  • K943042 — BUN QVET (December 29, 1994)
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