BIOTIS LD-PRESUMPTO QUADRANT PLATE— 510(k) K842424

Name: FDA 510(k) clearance K842424
Creator: U.S. Food and Drug Administration
Published: 1984-07-02

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K842424 for BIOTIS LD-PRESUMPTO QUADRANT PLATE, Substantially Equivalent on 1984-07-02. Applicant: Otisville Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code JSE
Device class: Class 1
Regulation: 21 CFR 866.2320
Advisory panel: Microbiology
Date received: 1984-06-20
Decision date: 1984-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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