FLUOR-B MEL A DIRECT FLUORESCENT ANTI— 510(k) K833613

Name: FDA 510(k) clearance K833613
Creator: U.S. Food and Drug Administration
Published: 1983-12-12

Substantially Equivalent

Petra Biomedical Products, Inc.

FDA 510(k) clearance K833613 for FLUOR-B MEL A DIRECT FLUORESCENT ANTI, Substantially Equivalent on 1983-12-12. Applicant: Petra Biomedical Products, Inc.. Device class: 1.

Clearance details

Applicant: Petra Biomedical Products, Inc.
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-10-13
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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