SYPHILIS IGM HUMAN SERUM CONTROLS— 510(k) K961317

Name: FDA 510(k) clearance K961317
Creator: U.S. Food and Drug Administration
Published: 1996-06-24

Substantially Equivalent

Pyramid Biological Corp.

FDA 510(k) clearance K961317 for SYPHILIS IGM HUMAN SERUM CONTROLS, Substantially Equivalent on 1996-06-24. Applicant: Pyramid Biological Corp.. Device class: 2.

Clearance details

Applicant: Pyramid Biological Corp.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1996-04-05
Decision date: 1996-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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