ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA— 510(k) K954515

Name: FDA 510(k) clearance K954515
Creator: U.S. Food and Drug Administration
Published: 1995-12-20

Substantially Equivalent

Pyramid Biological Corp.

FDA 510(k) clearance K954515 for ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA, Substantially Equivalent on 1995-12-20. Applicant: Pyramid Biological Corp.. Device class: 2.

Clearance details

Applicant: Pyramid Biological Corp.
Product code: Code GOM
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1995-09-28
Decision date: 1995-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

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