Last synced on 30 September 2022 at 11:05 pm

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974027
510(k) Type
Traditional
Applicant
ALFA BIOTECH (UK) LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/2/1998
Days to Decision
102 days
Submission Type
Summary

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974027
510(k) Type
Traditional
Applicant
ALFA BIOTECH (UK) LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/2/1998
Days to Decision
102 days
Submission Type
Summary