TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS— 510(k) K973784

Clearance details

Applicant

Biosite Incorporated

Product code

Code DKZ

Device class

Class 2

Regulation

21 CFR 862.3100

Advisory panel

Clinical Toxicology

Date received

1997-10-03

Decision date

1997-12-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973784.