GRAM STAIN SET W/STABILIZED IODINE— 510(k) K843429

Name: FDA 510(k) clearance K843429
Creator: U.S. Food and Drug Administration
Published: 1984-09-14

Substantially Equivalent

Accra Laboratories, Inc.

FDA 510(k) clearance K843429 for GRAM STAIN SET W/STABILIZED IODINE, Substantially Equivalent on 1984-09-14. Applicant: Accra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Accra Laboratories, Inc.
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-09-04
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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