Home / 510(k) Clearances / K823786

510(k) K823786

ALKALINE PHOSPHATASE by Analytical & Research Chemicals, Inc. — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 16, 1982
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 Analytical & Research Chemicals, Inc.

  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781323 — LDH PROCEDURE (August 31, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K781324 — ALP TEST (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)

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)