LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS— 510(k) DEN050002

Name: FDA 510(k) clearance DEN050002
Creator: U.S. Food and Drug Administration
Published: 2005-05-19

Unknown

Wako Chemicals USA, Inc.

FDA 510(k) clearance DEN050002 for LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS, Unknown on 2005-05-19. Applicant: Wako Chemicals USA, Inc.. Device class: 2.

Clearance details

Applicant: Wako Chemicals USA, Inc.
Product code: Code NSF
Device class: Class 2
Regulation: 21 CFR 866.6030
Advisory panel: Immunology
Date received: 2005-04-07
Decision date: 2005-05-19
Decision: Unknown
Clearance type: Post-NSE
Location: Richmond, VA, US

View on FDA.gov ↗

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