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510(k) K891574

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 by Em Diagnostic Systems, Inc. — Product Code JGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code JGT

  • K896829 — TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (February 23, 1990)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K840216 — SODIUM/POTASSIUM REAGENT SYS (March 19, 1984)
  • K834248 — PARALLEL FLAME PHOTOMETER & SODIUM (January 30, 1984)
  • K811886 — CESIUM DILUENT 7.5M (July 23, 1981)
  • K801892 — KLINAR REAGENT PAK, #36010 (October 23, 1980)
  • K770774 — LYTETEK SYSTEM (July 11, 1977)