CULTURE TEST FOR NEISSERIA GONORRHOEAE— 510(k) K771035

Name: FDA 510(k) clearance K771035
Creator: U.S. Food and Drug Administration
Published: 1977-07-05

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K771035 for CULTURE TEST FOR NEISSERIA GONORRHOEAE, Substantially Equivalent on 1977-07-05. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1977-06-10
Decision date: 1977-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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