Last synced on 29 August 2025 at 11:05 pm

NEONATAL BIOTINIDASE KIT, MODEL 3018

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090123
510(k) Type
Traditional
Applicant
PERKINELMER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/5/2010
Days to Decision
408 days
Submission Type
Summary

NEONATAL BIOTINIDASE KIT, MODEL 3018

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090123
510(k) Type
Traditional
Applicant
PERKINELMER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/5/2010
Days to Decision
408 days
Submission Type
Summary