ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS— 510(k) K952254

Name: FDA 510(k) clearance K952254
Creator: U.S. Food and Drug Administration
Published: 1995-11-16

Substantially Equivalent

Pyramid Biological Corp.

FDA 510(k) clearance K952254 for ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS, Substantially Equivalent on 1995-11-16. Applicant: Pyramid Biological Corp.. Device class: 2.

Clearance details

Applicant: Pyramid Biological Corp.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1995-05-15
Decision date: 1995-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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