KALLESTAD RSV MICROPLATE EIA— 510(k) K924289

Name: FDA 510(k) clearance K924289
Creator: U.S. Food and Drug Administration
Published: 1993-02-12

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K924289 for KALLESTAD RSV MICROPLATE EIA, Substantially Equivalent on 1993-02-12. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code MCE
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1992-08-21
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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