VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010— 510(k) K851504

Name: FDA 510(k) clearance K851504
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K851504 for VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010, Substantially Equivalent on 1985-08-19. Applicant: Ncs Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ncs Diagnostics, Inc.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1985-04-15
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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