RAICHEM(TM) ALCOHOL REAGENT— 510(k) K874382

Name: FDA 510(k) clearance K874382
Creator: U.S. Food and Drug Administration
Published: 1988-01-11

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K874382 for RAICHEM(TM) ALCOHOL REAGENT, Substantially Equivalent on 1988-01-11. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code DML
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1987-10-26
Decision date: 1988-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DML

view all

K013538 — ETHANOL2001-12-14
K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL2000-02-01
K963197 — ON.SITE ALCOHOL1996-09-19
K953765 — AXSYM REA ETHANOL1995-09-27
K952839 — BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY1995-08-24

More clearances from Reagents Applications, Inc.

view all

K982056 — RAICHEM CO2 REAGENT1998-06-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENT1997-09-24
K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1992-07-30
K915191 — RAI-TROL ELEVATED LIPIDS CONTROL1991-12-18
K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT1991-09-25

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