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510(k) K013983

WIENER LAB. ALP 405 by Wiener Laboratories Saic — Product Code CJE

K013983 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB. ALP 405". The FDA issued a decision of Substantially Equivalent on January 28, 2002. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2002
Date Received
December 3, 2001
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 Wiener Laboratories Saic

  • K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (February 11, 2004)
  • K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (March 18, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K024116 — WIENER LAB. BILIRUBINA DIRECT AA (February 12, 2003)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K023549 — WIENER LAB AMILASA 405 AA LIQUIDA (December 9, 2002)
  • K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K022962 — WIENER LAB. BILIRRUBINA TOTAL AA (November 1, 2002)
  • K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB. (September 10, 2002)

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)

FDA data resources