FDA.reportPublic FDA data

510(k) K012999

Device
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
Applicant
Biosite Incorporated
510(k) number
K012999
Product code
DIF
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-03
Date received
2001-09-06
Regulation
862.3280
Classification name
Drug Mixture Control Materials
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JEFFREY R DAHLEN
Address
11030 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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