PARAMAX ALCOHOL REAGENT— 510(k) K840769

Substantially Equivalent

American Dade

FDA 510(k) clearance K840769 for PARAMAX ALCOHOL REAGENT, Substantially Equivalent on 1984-04-13. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code DML
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1984-02-08
Decision date: 1984-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DML

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 American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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