AMYLASE REAGENT CS-726— 510(k) K844168

Name: FDA 510(k) clearance K844168
Creator: U.S. Food and Drug Administration
Published: 1984-11-20

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K844168 for AMYLASE REAGENT CS-726, Substantially Equivalent on 1984-11-20. Applicant: Fisher Scientific Co., LLC. Device class: 2.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code CJA
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1984-10-25
Decision date: 1984-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fair Lawn, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJA

view all

K895555 — MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)1989-12-22
K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS1988-12-09
K883059 — WAKO(TM) AUTOKIT AMYLASE1988-08-30
K873520 — PARAMAX AMYLASE REAGENT1987-11-23
K862640 — AMYLASE LTS1986-09-09

More clearances from Fisher Scientific Co., LLC

view all

K930415 — MICROHEMATOCRIT ROTOR1993-03-23
K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE1992-03-11
K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE1992-01-08
K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 11989-03-08
K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II1988-05-16

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