SODIUM HYPOCHLORITE 3%— 510(k) K831620

Name: FDA 510(k) clearance K831620
Creator: U.S. Food and Drug Administration
Published: 1983-07-28

Substantially Equivalent

Omega Medical Diagnostics

FDA 510(k) clearance K831620 for SODIUM HYPOCHLORITE 3%, Substantially Equivalent on 1983-07-28. Applicant: Omega Medical Diagnostics. Device class: 1.

Clearance details

Applicant: Omega Medical Diagnostics
Product code: Code PPM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1983-05-19
Decision date: 1983-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PPM

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K871533 — TOMTEC GRAM STAINER DECOLORIZER1987-04-29
K863550 — POTASSIUM HYDROXIDE 10% W/V1986-10-02
K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 21986-06-03
K850916 — SPRAYFIX1985-03-25
K850737 — TRANSPORT CULTURE MEDIUM1985-03-20

More clearances from Omega Medical Diagnostics

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K832182 — LYSING REAGENT1983-08-12
K831619 — SODIUM HYPOCHLORITE 7%1983-07-28
K831617 — DILUENT1983-06-16
K831618 — HEMOGLOBIN REAGENT1983-06-16

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