WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002— 510(k) K013652

Name: FDA 510(k) clearance K013652
Creator: U.S. Food and Drug Administration
Published: 2001-12-21

Substantially Equivalent

Wiener Laboratories Saic

FDA 510(k) clearance K013652 for WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002, Substantially Equivalent on 2001-12-21. Applicant: Wiener Laboratories Saic. Device class: 2.

Clearance details

Applicant: Wiener Laboratories Saic
Product code: Code CIC
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2001-11-06
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, Santa Fe, AR

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIC

view all

K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)2013-05-02
K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)2009-03-09
K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H2007-04-26
K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS2006-03-24
K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS2005-02-15

More clearances from Wiener Laboratories Saic

view all

K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 12032542004-02-11
K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 19180062003-03-18
K023992 — WIENER LAB COLINESTERASA AA2003-02-12
K024116 — WIENER LAB. BILIRUBINA DIRECT AA2003-02-12
K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 12713542003-01-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.