340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER— 510(k) K945408

Name: FDA 510(k) clearance K945408
Creator: U.S. Food and Drug Administration
Published: 1995-02-22

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K945408 for 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER, Substantially Equivalent on 1995-02-22. Applicant: Catachem, Inc.. Device class: 2.

Clearance details

Applicant: Catachem, Inc.
Product code: Code CHJ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1994-11-03
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHJ

view all

K010670 — PICCOLO CHLORIDE TEST SYSTEM2001-04-26
K943006 — CHLORIDE QVET1994-12-07
K934136 — OLYMPUS CHLORIDE REAGENT, MODIFICATION1993-11-05
K932528 — OLYMPUS CHLORID REAGENT, MODIFIED1993-09-17
K925338 — OLYMPUS CHLORIDE REAGENT1992-12-11

More clearances from Catachem, Inc.

view all

K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT2007-01-19
K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER1993-09-08
K903341 — MAGNESIUM1990-08-22
K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS1990-07-31
K902877 — TOTAL IRON FOR MANUAL/AUTOMATED1990-07-27

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