URIC ACID (URICASE) METHOD-II— 510(k) K863287

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K863287 for URIC ACID (URICASE) METHOD-II, Substantially Equivalent on 1986-09-29. Applicant: Catachem, Inc.. Device class: 1.

Clearance details

Applicant: Catachem, Inc.
Product code: Code JHC
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1986-08-25
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

More clearances from Catachem, Inc.

K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT2007-01-19
K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER1995-02-22
K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER1993-09-08
K903341 — MAGNESIUM1990-08-22
K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS1990-07-31

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