WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000— 510(k) DEN990008

Name: FDA 510(k) clearance DEN990008
Creator: U.S. Food and Drug Administration
Published: 2000-02-15

Unknown

Wallac, Inc.

FDA 510(k) clearance DEN990008 for WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000, Unknown on 2000-02-15. Applicant: Wallac, Inc.. Device class: 2.

Clearance details

Applicant: Wallac, Inc.
Product code: Code NAK
Device class: Class 2
Regulation: 21 CFR 862.1118
Advisory panel: Clinical Chemistry
Date received: 1999-12-20
Decision date: 2000-02-15
Decision: Unknown
Clearance type: Post-NSE
Location: Norton, OH, US

View on FDA.gov ↗

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