EMIT(R) IIC OPIATE ASSAY— 510(k) K935117

Clearance details

Applicant

Syva Co.

Product code

Code DJG

Device class

Class 2

Regulation

21 CFR 862.3650

Advisory panel

Clinical Toxicology

Date received

1993-10-27

Decision date

1994-01-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

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