BIOCULT - GC CULTURE-PADDLES— 510(k) K831124

Name: FDA 510(k) clearance K831124
Creator: U.S. Food and Drug Administration
Published: 1983-05-09

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K831124 for BIOCULT - GC CULTURE-PADDLES, Substantially Equivalent on 1983-05-09. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1983-04-05
Decision date: 1983-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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