ALCOHOL REAGENT SET— 510(k) K972725

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K972725 for ALCOHOL REAGENT SET, Substantially Equivalent on 1997-09-25. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1997-07-21
Decision date: 1997-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIC

K250609 — Sober Self-Test2025-09-15
K181553 — Immunalysis Ethyl Alcohol Enzyme Assay2018-10-31
K121247 — ALCO-SCREEN2013-03-22
K121256 — ALCO-SCREEN 022012-09-12
K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL2011-11-15

More clearances from Pointe Scientific, Inc.,

K070757 — MICROPROTEIN REAGENT SET2007-12-04
K062118 — POINTE 3602007-07-13
K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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