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510(k) K880339

EASY-TEST POTASSIUM K ITEM NUMBER 19XXX by Em Diagnostic Systems, Inc. — Product Code CEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1988
Date Received
January 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetraphenyl Borate, Colorimetry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

Other clearances for product code CEJ

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  • K943026 — POTASSIUM QVET (December 9, 1994)
  • K904033 — REFLOTRON POTASSIUM TEST TABS (November 6, 1990)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K883585 — TECHNICON ASSIST POTASSIUM (November 29, 1988)
  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
  • K881440 — IQ POTASSIUM (May 27, 1988)
  • K863486 — POTASSIUM TEST (September 29, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)
  • K853404 — QCA POTASSIUM TEST KIT (August 23, 1985)