Home / 510(k) Clearances / K935182

510(k) K935182

EMDS ALKANINE PHOSPHATASE (ALP) TEST by Em Diagnostic Systems, Inc. — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1993
Date Received
October 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
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)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code CJE

  • K251074 — Tru Liver Health Test Panel (December 19, 2025)
  • K240468 — Alkaline Phosphatase (October 16, 2024)
  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 (January 25, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)